Bausch + Lomb Jobshttp://bausch.jobs2012-05-23 10:49:32.674041USARochester Global Eye Health Center SiteTitle: Engineer II, Optics Location: United States-New York-Rochester Global Eye Health Center Site Position Summary: Develop and implement innovative designs of optical ophthalmic devices (e.g. contact lenses) and optical systems utilizing optical and mechanical modeling / design systems and statistical data analysis. Identify, develop and implement optical testing methods or capabilities for measuring ophthalmic optical devices or components. Provide technical expertise in optical design, testing and data analysis in advancing design methodologies and capabilities. Specific Job Duties: * Interface w/ customers and internal functions to define and develop optical specifications and designs. * Develop optical designs using opto-mechanical modeling and data analysis. * Develop models of optical systems and perform simulations to predict optical performance. * Prepare design documentation including drawings, models, specifications and release documents. * Participate on product development teams acting as optics design / technology expert throughout the development process. * Identify / develop optical testing methods or capabilities for measuring optical ophthalmic devices. * Prepare reports summarizing optical design, testing and/or development data. * Develop and implement design methods for conceptualizing and optimizing optical designs for ophthalmic devices or optical systems. * Develop and implement procedures of design and testing methods. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. MS Optical Engineering or related curriculum w/ 2-5 yrs relevant industrial experience. Strong verbal and written communication. Strong problem solving skills. Required skills include:Demonstrated expertise in developing Optical models and system designs. Proficient w/ Zemax or other optical modeling software. Experience w/ optical system design, assembly/alignment and testing. Experience w/ statistical analysis and associated tools (e.g. Statistica, Minitab…). Strong skills using MS Office product (Excel, Word, PPT). Programming capabilities (e.g. Matlab, VB, C ). Desired skills include:Familiar w/ medical device design requirements. Familiar w/ regulated development environment (FDA or ISO). Job: Research/Development2012-05-22 19:09:21United StatesBausch + LombNew York00007726NYRochester Global Eye Health Center Site, NY28867091http://bausch.jobs/xml/28867091/jobUSARochester Global Eye Health Center SiteTitle: Senior Principal Scientist, Polymer Chemistry Location: United States-New York-Rochester Global Eye Health Center Site Position Summary A major component of our current research effort is directed toward the development of new, high-performance biomedical materials with primary application toward contact lenses. This position is to perform formulation and process research to create novel contact lens materials. Specific Job Duties * Design, synthesis and analysis of chemistries used for contact lens materials and lens care solutions * Conceives ideas, tests and develop solutions to solve chemistry, process and analytical issues * Present results in both written and oral formats * Literature and patent reviews * Assists with patent portfolio strategy development * Conversant with statistical experimental designs Competencies * Business impact: Organic/polymer chemist with strong emphasis on contact lens formulation, polymerization and processes. * Organizes, leads, and carries out work on projects of significant scale, complexity, or priority. * Scope of impact: Conceives ideas, tests, develops and solves technical problems. Conceives state-of-the-art and innovative process design to solve significant processing problems. Conceives/applies state of the industry solutions to projects or product applications. Develops and implements ideas to technical projects/problems. * Contribution/Role: Expected to have 2 documented, demonstrated and/or *published original or innovative idea or other essential contributions, such as improved methods, instrument or technique, or process equipment innovation or software systems, published clinical papers or has at least 2 patents applications filed (or I.D., which the company has elected not to file for strategic reasons.) * Level of empowerment: Refines, improves execution, implements * Scope of impact: Makes team or project recommendations and decisions Depth of Expertise * In-depth understanding of primary function, concepts & philosophies * Breadth of Expertise: General assignments, project management within function, technical leader. * Problem Solving: Conceives technology solutions and applies to solve problems of high complexity with independence. * Customer focus: Customer/vendor contact primarily to problem solve Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. * Ph.D. in Chemistry/Polymer Chemistry/ Material Science or Chemical Engineering * 6 years relevant work experience * Skilled in laboratory practices Managerial responsibilities: Supervises non-exempts and/or exempt employees. Provides direction to subordinates based on program objectives and management guidance. Job: Research/Development2012-05-17 18:30:30United StatesBausch + LombNew York00007717NYRochester Global Eye Health Center Site, NY28763168http://bausch.jobs/xml/28763168/jobUSARochester Global Eye Health Center SiteTitle: Principal Research Optometrist, Clinical Research Location: United States-New York-Rochester Global Eye Health Center Site The Principal Research Optometrist reports directly to the Director of Clinical Affairs. Design and executes clinical studies for the evaluation of developmental contact lenses, lens care solutions, and general eye care products; analyze study data and write technical reports and is expected to maintain current optometric knowledge and skills. Specific Job Duties Represent clinical affairs, independently or with minimal supervision. Interface with D & R technical teams on project needs, interpretation of voice of customer data and interpreting the end product requirement. Design and execute clinical studies for the evaluation of developmental contact lenses, lens care solutions, and general eye care products; analyze study data and write technical reports. * Design and conduct clinical studies in support of developmental or core research projects, process validations, cost improvement efforts, and Marketing assistance/competitive analyses. * Conduct statistical analyses of study data and write technical reports. * Interpret clinical data and contribute to clinical reports. * Present clinical results in professional literature and professional conferences. * Represent Clinic on assigned R & D project teams; provide directional feedback. * Support global operations re: technical inquiries. * Participate on contact lens and lens care project development teams as clinical representative, and contribute to the development of clinical strategy and field clinical study protocols/reports to support organizational strategies. * Evaluate new technologies and competitive products for assessment of contact lens and lens care clinical performance. * Keep current on existing technologies, competitive products, new techniques, B L SOPs and Good Clinical Practice (GCP). Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Education: * Bachelor’s degree required Doctor of Optometry or equivalent (OD, MS Optom); * MS/PhD preferred Experience: * 2 years of clinical experience; * Experience in cross-functional, multi-cultural and international trial teams is a plus * Clinical Research experience preferred * 3 years of dedicated clinical practice Managerial Responsibility 3 years of successfully leading technicians and clinicians in a clinical environment with proven ability to lead and manage through change. Up to 3 direct reports. Job: Research/Development2012-05-17 18:30:22United StatesBausch + LombNew York00007718NYRochester Global Eye Health Center Site, NY28763151http://bausch.jobs/xml/28763151/jobUSARochester Global Eye Health Center SiteTitle: Principal Research Optometrist, Clinical Research Location: United States-New York-Rochester Global Eye Health Center Site The Principal Research Optometrist reports directly to the Director of Clinical Affairs. Design and executes clinical studies for the evaluation of developmental contact lenses, lens care solutions, and general eye care products; analyze study data and write technical reports and is expected to maintain current optometric knowledge and skills. Specific Job Duties Represent clinical affairs, independently or with minimal supervision. Interface with D & R technical teams on project needs, interpretation of voice of customer data and interpreting the end product requirement. Design and execute clinical studies for the evaluation of developmental contact lenses, lens care solutions, and general eye care products; analyze study data and write technical reports. * Design and conduct clinical studies in support of developmental or core research projects, process validations, cost improvement efforts, and Marketing assistance/competitive analyses. * Conduct statistical analyses of study data and write technical reports. * Interpret clinical data and contribute to clinical reports. * Present clinical results in professional literature and professional conferences. * Represent Clinic on assigned R & D project teams; provide directional feedback. * Support global operations re: technical inquiries. * Participate on contact lens and lens care project development teams as clinical representative, and contribute to the development of clinical strategy and field clinical study protocols/reports to support organizational strategies. * Evaluate new technologies and competitive products for assessment of contact lens and lens care clinical performance. * Keep current on existing technologies, competitive products, new techniques, B L SOPs and Good Clinical Practice (GCP). Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Education: * Bachelor’s degree required Doctor of Optometry or equivalent (OD, MS Optom); * MS/PhD preferred Experience: * 2 years of clinical experience; * Experience in cross-functional, multi-cultural and international trial teams is a plus * Clinical Research experience preferred * 3 years of dedicated clinical practice Managerial Responsibility 3 years of successfully leading technicians and clinicians in a clinical environment with proven ability to lead and manage through change. Up to 3 direct reports. Job: Research/Development2012-05-08 19:49:55United StatesBausch + LombNew York00007701NYRochester Global Eye Health Center Site, NY28547049http://bausch.jobs/xml/28547049/jobUSARochester Global Eye Health Center SiteTitle: Senior Regulatory Affairs Specialist Location: United States-New York-Rochester Global Eye Health Center Site Responsible for providing Regulatory Affairs support to gain or maintain regulatory authorizations to market medical device products in the various markets. This position requires the incumbent to prepare various country submissions, review and approve product labeling & advertising, support facility inspections and participate in other regulatory support activities as required. Participate on new product development teams. Support regulatory compliance activities. Specific Job Duties: • With the oversight of a Regulatory Manager, develops regulatory strategies including incorporating worldwide regulatory requirements and timelines for product development and product improvement projects. • Generate submissions (i.e. PMA, 510(k), PMA supplements, CE marking applications, country specific product registrations, etc.) to obtain various worldwide approvals to commercially distribute products. This requires participation in product development teams, as well as, responsibility to review, analyze and comment on technical reports. This also requires interaction with US and non-US government officials on product submissions and approvals. • Produce subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of product approvals. • Review and approve labeling and advertising of B & L device products. • Review and provide input to technical protocols and reports from D & R. • Review and provide input on departmental policies and procedures. • Provide input and comment to regulations and standards which may affect B & L device products. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. • BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law. Additional professional training would be of value. • Experience - Knowledge of medical device or drug GMP's required. Experience in medical device product development and/or manufacturing highly desired. Minimum 3-5 years experience in medical device industry with experience in Quality or Regulatory disciplines. Experience preparing non-US medical device registrations highly desired. Special skills: Good working knowledge of U.S. FDA medical device regulations and guidance documents. Must have excellent communication, organization, time management and writing skills. Strong interpersonal skills required in areas of verbal and written communications, service to internal customers, and professionalism. Strong questioning and problem-solving skills. Must be self-motivated by working independently and having the ability to take ownership of his/her responsibilities. Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions. Must have command of English language. Computer literate with general office software and internet use. Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures. Ability to write routine reports and business correspondence. Ability to effectively present information in one-on-one and small group situations to internal customers and other employees of the organization. No direct reports. Job: Research/Development2012-05-02 18:54:09United StatesBausch + LombNew York00007681NYRochester Global Eye Health Center Site, NY28332991http://bausch.jobs/xml/28332991/jobUSATampa SiteTitle: Scientist Location: United States-Florida-Tampa Site Position Summary The scientist in this role develops and applies chemical and physical measurements to assess quality and performance of products and materials used in those products for the pharmaceutical business unit. This work is integral to new product development and for the maintenance of existing products. Specific Job Duties The collaborative nature of this position requires that the individual works as part of a team, communicates openly with others and accepts responsibility for timely execution of experiments intended to provide chemical understanding and results. · In order to assure the development of appropriate testing methods and strategies, the individual is expected to make every effort think about molecules in a chemical and/or physical environment. · In collaboration with a more senior scientist, develop tests and generate data to answer the questions necessary for the development of new products and for the maintenance of existing products. · In a timely manner, independently validate analytical methods (both chemical and physical) to meet development timelines with quality suitable for regulatory submission. · Document findings in laboratory notebooks and reports, as appropriate, in a timely manner. · Perform stability testing of prototype, GLP, and GMP pharmaceutical products in a timely manner. · Perform periodic laboratory audits. · Assist with general laboratory housekeeping. Maintain and replace inventory of supplies and chemicals, as needed. * Education: Bacheloreate degree (in Chemistry pref. or other physical or biological science discipline). * Must have solid knowledge of the basis for common analytical techniques (e.g., molecular interactions related to chromatography, be able to explain a titration and colorimetric test). * Familiarity with chemistry fundamentals is essential (e.g., molarity, acid, base, buffering, pKa, Ksp, simple organic chemistry reactions.). * A basic understanding of organic chemistry is preferred. Special Skills: Highly desired: Previous laboratory experience involving cGMP analytical method development (e.g., pharmaceutical method analysis, quality control testing - including development of methods, validation and/or transfer) Desired: Spectroscopy, organic synthesis, familiarity with manufacturing processes, statistics, titration, physical testing methods (e.g., dissolution, rheology, particle size) Familiarity with cGMP, GLP, FDA, ICH guidance. Training: Familiarity with Waters’ Empower chromatography data software. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world–from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Job: Research/Development2012-04-27 19:58:00United StatesBausch + LombFlorida00007678FLTampa Site, FL28240306http://bausch.jobs/xml/28240306/jobUSARochester Global Eye Health Center SiteTitle: Scientist Location: United States-New York-Rochester Global Eye Health Center Site Position Summary The scientist in this role develops and applies (primarily) physical measurements to assess quality and performance of products and materials used in those products for the pharmaceutical business unit. This work is integral to new product development and for the maintenance of existing products. The focus of this position is on micrometerics, particulate and particle size distribution measurement. Specific Job Duties The collaborative nature of this position requires that the individual works as part of a team, communicates openly with others and accepts responsibility for timely execution of experiments intended to provide chemical understanding and results. · In order to assure the development of appropriate testing methods and strategies, the individual is expected to make every effort think about molecules in a chemical and/or physical environment. · In collaboration with a more senior scientist, develop tests and generate data to answer the questions necessary for the development of new products and for the maintenance of existing products. · In a timely manner, independently validate analytical methods (both chemical and physical) to meet development timelines with quality suitable for regulatory submission. · Document findings in laboratory notebooks and reports, as appropriate, in a timely manner. · Perform stability testing of prototype, GLP, and GMP pharmaceutical products in a timely manner. · Perform periodic laboratory audits. · Assist with general laboratory housekeeping. Maintain and replace inventory of supplies and chemicals, as needed. * Education: Bacheloreate degree (in Chemistry pref. or other physical or biological science discipline). * Must have solid knowledge of the basis for common analytical techniques (e.g., molecular interactions related to chromatography, be able to explain a titration and colorimetric test). * Familiarity with chemistry fundamentals is essential (e.g., molarity, acid, base, buffering, pKa, Ksp, simple organic chemistry reactions.). * A basic understanding of organic chemistry is preferred. Special Skills: Highly desired: Familiarity with manufacturing processes, statistics, titration, physical testing methods (e.g., dissolution, rheology, particle size measurement, microscopy) Desired: Previous laboratory experience involving cGMP analytical method development (e.g., pharmaceutical method analysis, quality control testing - including development of methods, validation and/or transfer). Familiarity with cGMP, GLP, FDA, ICH guidance. Training: Familiarity with Waters’ Empower chromatography data software. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world–from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Job: Research/Development2012-04-27 19:57:51United StatesBausch + LombNew York00007680NYRochester Global Eye Health Center Site, NY28240299http://bausch.jobs/xml/28240299/jobUSARochester Global Eye Health Center SiteTitle: Scientist Location: United States-New York-Rochester Global Eye Health Center Site Position Summary The scientist in this role develops and applies chemical and physical measurements to assess quality and performance of products and materials used in those products for the pharmaceutical business unit. This work is integral to new product development and for the maintenance of existing products. Specific Job Duties The collaborative nature of this position requires that the individual works as part of a team, communicates openly with others and accepts responsibility for timely execution of experiments intended to provide chemical understanding and results. · In order to assure the development of appropriate testing methods and strategies, the individual is expected to make every effort think about molecules in a chemical and/or physical environment. · In collaboration with a more senior scientist, develop tests and generate data to answer the questions necessary for the development of new products and for the maintenance of existing products. · In a timely manner, independently validate analytical methods (both chemical and physical) to meet development timelines with quality suitable for regulatory submission. · Document findings in laboratory notebooks and reports, as appropriate, in a timely manner. · Perform stability testing of prototype, GLP, and GMP pharmaceutical products in a timely manner. · Perform periodic laboratory audits. · Assist with general laboratory housekeeping. Maintain and replace inventory of supplies and chemicals, as needed. * Education: Bacheloreate degree (in Chemistry pref. or other physical or biological science discipline). * Must have solid knowledge of the basis for common analytical techniques (e.g., molecular interactions related to chromatography, be able to explain a titration and colorimetric test). * Familiarity with chemistry fundamentals is essential (e.g., molarity, acid, base, buffering, pKa, Ksp, simple organic chemistry reactions.). * A basic understanding of organic chemistry is preferred. Special Skills: Highly desired: Previous laboratory experience involving cGMP analytical method development (e.g., pharmaceutical method analysis, quality control testing - including development of methods, validation and/or transfer) Desired: Spectroscopy, organic synthesis, familiarity with manufacturing processes, statistics, titration, physical testing methods (e.g., dissolution, rheology, particle size) Familiarity with cGMP, GLP, FDA, ICH guidance. Training: Familiarity with Waters’ Empower chromatography data software. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world–from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Job: Research/Development2012-04-27 19:57:36United StatesBausch + LombNew York00007679NYRochester Global Eye Health Center Site, NY28240283http://bausch.jobs/xml/28240283/jobUSASt Louis SiteTitle: Mechanical Engineer II Location: United States-Missouri-St Louis SitePosition Summary The Mechanical Engineer II will apply principles of mechanical engineering to perform activities in support of the engineering analysis and mechanical design of cataract and vitreoretinal ophthalmic surgical equipment and disposables. This person will be a contributing technical member on product design programs. Primary activities will include creating CAD models of components, assemblies, and drawings in Solid Works, performing product engineering analysis and root cause investigations, write technical documents such as test protocols and reports, engineering analyses, and technical specifications. Additionally this person may be assigned to be the project manager on projects of limited scope. Other duties to be completed as assigned. Specific Job Duties Design, test, and transfer to production new single-use disposable products, electro-mechanical, and fluidic product designs. Ensure proper design documentation, and verification testing, is completed. Maintain existing single-use disposable products, electro-mechanical, and fluidic product designs, implementing revisions as required to support manufacturing or improve product performance. Create CAD models of components, assemblies, and create drawings using CAD design program (Solid Works). Review and author technical documents including technical specifications, test protocols, test reports, engineering analyses and product DFMEAs Perform root cause investigations on product defects and generate summary reports of analysis and conclusions. Technical leader of project teams coordinating the efforts of others on sustaining engineering projects. Work with Operations to ensure the single-use disposable, electro-mechanical, and fluidic designs are capable of being fabricated on a consistent and repeatable basis. Participate in project planning activities and project design review meetings as required. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Education: Bachelor of Science degree in Mechanical Engineering. Experience: 5 years experience in electro-mechanical or fluidics design of consumer products. Design experience with medical products is preferred. Special Skills: Solid Works CAD design, Finite Element Analysis (FEA) with Solid Works Simulation, root cause analysis techniques, and technical writing Specialized Training: Design for Six Sigma (DFSS) Managerial Responsibility None Job: Research/Development2012-04-25 20:12:01United StatesBausch + LombMissouri00007674MOSt Louis Site, MO28181215http://bausch.jobs/xml/28181215/jobUSARochester Global Eye Health Center SiteTitle: Senior Manager, Corporate Development & Research Operations Location: United States-New York-Rochester Global Eye Health Center Site Position Summary: The Sr. Manager, Corporate D & R Operations will manage a group of 3 direct reports (total organization of 7) with responsibilities across the 3 business units. Key functions of the organization include: D & R Portfolio, PCPF process ownership (PMO), Clinical QA, and the technical library function. * Portfolio – management of the Kintana resource planning and tracking tool, system administration, report development, training, and process improvements. Improvement of D & R business case process, maintenance, including working with business units to get regular updates to project valuations, assumptions, and risk evaluations. Keeper of D & R pipeline documents for communication to internal and external audiences. * PCPF / PMO – work with business units to implement a consistent Patient Centered Product Flow commercialization process. Manage the centralized Project Management Office in support of the 3 business units. * Clinical QA – group that develops and implements clinical quality systems to ensure that clinical studies are run in compliance with Good Clinical Practices. * Technical Library – Manage resources to support scientific research, patent/legal, and regulatory affairs information critical to the development of new products and expansion into new markets. * Misc – other cross business units, D & R administrative activities such as university / professional organization liaison and D & R facility/space coordination Specific Job Duties * Manage D & R Operations group, leverage resources across business units * Support D & R Portfolio Management functions (e.g. business case development, resource planning) for the corporation and develop improvements * Implement Patient Centered Product Flow in a consistent manner across the business units * Ensure that appropriate clinical quality systems are in place and that clinical studies are conducted in a manner compliant with GCPs and B L requirements. * Manage the library / information services function for the corporation. Ensure that appropriate resources are in place to support new product development and geographic expansion of products associated with all Business units. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. * Candidate will have education and experience in technical area, especially as related to Medical Device and Pharmaceutical development. Business process, quality systems experience, and a BS in Science and/or Engineering preferred. Managerial Responsibility * Manage three direct reports, and a total organization of 7 (excluding contractors) Job: Research/Development2012-04-19 20:06:13United StatesBausch + LombNew York00007660NYRochester Global Eye Health Center Site, NY28011258http://bausch.jobs/xml/28011258/jobUSARochester Global Eye Health Center SiteTitle: Validation Principal Engineer, Solutions Process Development Location: United States-New York-Rochester Global Eye Health Center Site Position Summary Individual will be responsible for leading validation & qualification requirements in the D & R Solutions Process Development Pilot Facility in accordance with B L Global Quality Elements, FDA regulations and ISO standards. Activities include preparation and execution of validation strategies, FAT, IQ, OQ, PQ & PV, et. al. (qualification and validation) protocols and reports for equipment, utilities and processes. This individual will be responsible for maintenance of the Validation Master Plan, and the design; specification requirements; design reviews; installation and startup of new equipment; design changes and modifications of existing equipment; and utilities that support the D & R Solutions Process Development Pilot Facility. Specific Job Duties * Maintain an annual Validation Master Plan and a validation archive for Process Development. Coordinate validation, qualification and requalification activities per Validation Master Plan to maintain utilities, equipment and processes in a validated and qualified state. * Prepare IQ, OQ, PQ & PV validation protocols and final reports for Process Development. Provide guidance for troubleshooting during validation activities as warranted, and review and analyze data generated during validation activities. * Major participant in the selection of appropriate vendors for Pilot Facility’s equipment and utilities’ purchases and modifications. * Prepare plans, timing estimates, scope of work and bid documents as necessary for equipment purchase/ modifications and utilities installation for the Process Development organization with internal maintenance facilities and/or external contractors. Work with selected vendors and affected parties to schedule work for minimum business impact. * Provide cleaning and sterilization validation strategies for Process Development. * Act as an engineering technical resource for equipment trouble shooting and problem solving as necessary to maintain schedules in the Process Development Department. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Bachelors Degree in Mechanical, Chemical, or Biomedical Engineering or equivalent science–based degree required. Minimum of 8 to 10-years in an engineering or equivalent position in a pharmaceutical or medical device manufacturing or research environment. Experience with Purified Water Systems, Clean Steam Systems, Autoclave, Cleanrooms, HVAC Systems and aseptic processing are highly desirable. Knowledgeable of cGMPs for medical devices and pharmaceutical a must. Managerial Responsibility Independent contributor responsible for coordinating efforts to indirect reports. Job: Research/Development2012-04-19 20:06:08United StatesBausch + LombNew York00007661NYRochester Global Eye Health Center Site, NY28011256http://bausch.jobs/xml/28011256/jobUSARochester Global Eye Health Center SiteTitle: Senior Manager, Analytical and Material Sciences Location: United States-New York-Rochester Global Eye Health Center Site Position Summary The Senior Manager of the Materials Science Group leads a D & R (Development & Research) functional group with overall responsibility for Materials Characterization for the Vision Care Business Unit. This role will focus on managing the laboratories involved in pre-development and technical trouble shooting activities. This role will have oversight to the formulation and execution of characterization strategies that address unexpected issues in the product development and process development phases of PCPF (Patient Centered Product Flow) process. This role will ensure the ready availability of materials characterization methods that supplement the development phase activities of the PCPF process – specifically in gathering enough material understanding to charter from pre-development to development activities. This role will ensure that a fundamental understanding of product material is linked to product performance. The Manager of this role will report directly to the Senior Director of D & R Operations. Specific Job Duties * To provide scientific leadership to Bausch Lomb in bringing new technical capabilities to solve product related issues. * To manage a group of technical associates that design materials characterization experiments with the aim of increasing the knowledge-base of B L chemistry. * To drive the deployment of materials characterization methods to provide actionable insights into the chemical-material attributes which govern product performance – and from this provide new innovative opportunities. * To ensure that characterization-driven insights are fully leveraged in the selection, optimization, and scale-up of product designs, for programs and projects proceeding into the development phase process. * To provide a technical consulting resource for chemical-material issues related to marketed products. * Interface with cross functional partners in Quality, Regulatory, Commercial and D & R to align with the most critical characterization opportunities. * Contribute to the timely execution of analytical chemistry strategies to enable on-time product launches. * Develop associates within the Materials Science Group based on their capabilities and the business needs. * Interface with Program and Project leaders to facilitate the effective application of materials characterization inputs. * Interface with external technical resources, including academic resources, to provide the timely delivery of materials characterization solutions. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Education: Masters degree in Chemistry or related field with 10 years experience within an analytical chemistry group. Ph.D. in chemistry or related field with minimum 7 years experience within an analytical chemistry group. Experience: Candidates having experience in the medical device industry will be preferred. Candidate must have a minimum of three years managing people. Personal Skills: Candidates will be evaluated based on their ability to communicate technical information to technical and non-technical people. Candidates will be evaluated on their demonstrated experience of fostering new technology in order to maintain a relevant laboratory that matches changing product technology. Candidates will be evaluated on their record of developing associates throughout their career. Managerial Responsibility: There are approximately 20 associates that will report in through this role. Job: Research/Development2012-04-18 18:05:54United StatesBausch + LombNew York00007642NYRochester Global Eye Health Center Site, NY27976984http://bausch.jobs/xml/27976984/jobUSARochester Global Eye Health Center SiteTitle: Scientist, Analytical and Materials Sciences Location: United States-New York-Rochester Global Eye Health Center Site Position Summary: This Corporate D R position supports new product development and maintenance of business projects by providing method development, validation, transfer, and trouble-shooting for analytical methods. Specific Job Duties: * Analysis of developmental formulations using HPLC, UV-Vis, GC, and other common analytical techniques * Development of new analytical methods * Validation of new analytical methods * Trouble-shooting and support for marketed products / interaction with other B L facilities including Greenville and Milan. * Technical writing including research test procedure (RTP), standard operating procedures (SOP), test procedures (TP), central file reports (CFR), and method validation reports * Technical data review * Attend and participate in technical meetings Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Qualifications: BS in Chemistry or related field required and a minimum of 1-3 years of relevant laboratory experience involving HPLC, GC, UV-Vis. Knowledge of Waters Empower software electro-chemistry and polymer characterization is a plus. The candidate must also have experience performing analytical method development and validation. Experience working in a GMP compliant laboratory. Managerial Responsibility: The position does not involve any managerial or supervisory responsibilities Job: Research/Development2012-04-17 18:50:56United StatesBausch + LombNew York00007655NYRochester Global Eye Health Center Site, NY27949011http://bausch.jobs/xml/27949011/jobUSARochester Global Eye Health Center SiteTitle: Technician IV, Microbiology Location: United States-New York-Rochester Global Eye Health Center Site Position Summary Will become integral member of Antimicrobial Preservative Effectiveness Testing Team. Will be responsible for validating test methods and testing all development products for preservative efficacy; for performing in-use testing and discard date testing. Will be responsible for hands-on testing as well as data review. Assist in writing protocols and final reports supporting the work that this position will perform. Will be involved in laboratory investigations. Responsible for working in and maintaining a GMP environment. Specific Job Duties Will be responsible for preparing cultures for challenge testing; setting up, and executing preservative efficacy testing, in-use testing, and discard date testing in support of D & R activities. Will be responsible for validation of test methods; peer review of preservative efficacy studies. Will be responsible for documentation, contribute to protocol and report writing and initiating laboratory investigations. Will be responsible for prioritizing work to ensure development projects maintain proposed timelines. Will be working with LIMS, GLIMS, and involved in efficiency improvements to methodology. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Qualifications Qualified applicants should possess a minimum of an Associates degree in Microbiology/Medical Technology (Bachelors degree preferred) or alternatively in some other branch of Biology, plus 1-3 years experience in a laboratory setting. Managerial Responsibility No direct reports. Job: Research/Development2012-04-16 19:34:00United StatesBausch + LombNew York00007654NYRochester Global Eye Health Center Site, NY27928180http://bausch.jobs/xml/27928180/jobUSARochester Global Eye Health Center SiteTitle: Engineer I, Design Location: United States-New York-Rochester Global Eye Health Center Site Position Summary: Develop and implement innovative designs of optical ophthalmic devices (e.g. contact lenses) utilizing optical and mechanical modeling / design systems and statistical data analysis.. Act as product advocate through product development and commercialization process. Provide technical expertise in product design, material properties and data analysis in advancing design methodologies and capabilities. Specific Job Duties: 1. Interface w/ customers and internal functions to define and develop product specifications and designs 2. Develop contact lens designs using mechanical / optical modeling and data analysis 3. Prepare design documentation including drawings, models, specifications and release documents. 4. Prepare and monitor product testing (clinical and bench) requests 5. Participate on product development teams acting as product advocate throughout the development process 6. Perform data analysis of processing data during product/process development 7. Prepare reports summarizing product design, testing and/or development data 8. Develop and implement design methods for conceptualizing and optimizing contact lens designs 9. Develop and implement procedures of design methods Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Qualifications : MS Mechanical Engineering, Biomedical Engineering or related curriculum w/ 0-2 yrs relevant industrial experience. Strong verbal and written communication. Strong problem solving skills Required skills include: Demonstrated expertise in developing mechanical models and designs. Proficient w/ Solidworks or other 3D modeling software. Experience w/ statistical analysis and associated tools (e.g. Statistica, Minitab…). Strong skills using MS Office product (Excel, Word, PPT). Programming capabilities (e.g. Matlab, VB, C …) Desired skills include: Experience in optical design and analysis software. Experience w/ Finite Element Analysis (FEA) concepts and methodologies. Familiar w/ medical device design requirements. Familiar w/ regulated development environment (FDA or ISO). Managerial Responsibility: No functional direct reports. Job: Research/Development2012-03-20 21:02:38United StatesBausch + LombNew York00007609NYRochester Global Eye Health Center Site, NY27273398http://bausch.jobs/xml/27273398/jobUSARochester Global Eye Health Center SiteTitle: Technician III, Microbiology Location: United States-New York-Rochester Global Eye Health Center Site Position Summary: Work in regulated GMP lab environment. Perform preparation of sterile media, buffers, dry goods and the processing of biohazardous wastes. Maintain media preparation and glassware areas within the department. Write and update SOPs. Perform standard microbiology work using aseptic technique, excellent documentation skills. Specific Job Duties: * Performing preparation of sterile media, buffers, dry goods and processing of biological waste according to standards in support of manufacturing and R & D requirements. Maintain kitchen and glassware areas within the department. * Writing SOPs and reports * Perform standard microbiology work using aseptic technique, excellent documentation skills Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. * Education: High School Degree/Equivalent Required; AAS, BA or BS in Microbiology, Medical Technology, or related discipline preferred. * Experience: 1-5 years experience in a laboratory environment, preferably in industry such as pharmaceuticals, medical device, consumer products, biotech, etc. * Special Skills: aseptic technique, attention to detail, analytical aptitude * Specialized Training: GMP Training Job: Research/Development2012-03-19 19:04:29United StatesBausch + LombNew York00007599NYRochester Global Eye Health Center Site, NY27240861http://bausch.jobs/xml/27240861/jobUSARochester Global Eye Health Center SiteTitle: Senior Clinical DB Specialist (Data Manager) Location: United States-New York-Rochester Global Eye Health Center Site Position Summary : This position is responsible for planning and driving data management activities, managing data management timelines, and mentoring/supervising clinical data coordinators. They oversee all data management activities for a moderate to significant number of projects, depending on complexity, serving as the project manager for data management. Specific Job Duties : For a moderate to large number of projects, perform the following tasks: * Oversight of all DM activities * Serve as Clinical Trial Team lead for DM * Manage timelines * Oversee user acceptance testing (UAT) * Create edit check specifications * Create CRF completion guidelines * Provide eCRF design (layout) * Provide input during protocol review * Oversee change management * Review queries generated by CDCs, as needed * Facilitate/track data listing reviews * Work with external data sources to reconcile data * Unlock data, if necessary (prior to locking the entire database) * Manage study release (Go Live!) * Oversee all DB lock activities * Mentor/Supervise Clinical Data Coordinator(s), if applicable Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Required: * Bachelors or Master’s degree (preferably in a scientific or medical field). * At least five years experience in data management, with a track record of progressively increasing responsibility. * At least 3 years of Project Management experience. * Experience with research trials. Preferred: * Data management experience in a research clinic setting. * 5 years of Project Management experience. * 2 years of experience with EDC, preferably with eCRF development, user acceptance testing, and deployment. * Experience with both Pharma and Device trials. Ocular experience a plus. Technical Competencies: * Working knowledge of clinical research and clinical data management processes, GCP, and regulatory guidance * Proven ability to function as lead data manager on projects * Strong problem solving skills and excellent organizational skills with the ability to adapt to multiple priorities * Proven attention to detail; ability to proofread and check documents for accuracy and inconsistencies Professional Competencies: * Demonstrated ability in analytical reasoning and critical thinking skills * Strong capability to contribute and lead a team environment * Excellent communication skills; both oral and written * Strong interpersonal skills with the ability to influence others in a positive and effective manner * Demonstrated ability to contribute to a continuous learning and process improvement environment * Capacity to react quickly and decisively in unexpected situations * Focused ability to influence operational excellence and performance metrics * Able to identify potential solutions to complex problems Job: Research/Development2012-03-02 23:56:51United StatesBausch + LombNew York00007575NYRochester Global Eye Health Center Site, NY26903858http://bausch.jobs/xml/26903858/jobUSAMadison SiteTitle: Director, Head of Statistics Location: United States-New Jersey-Madison Site Manage the Pharmaceutical statistics group; providing leadership to the Pharmaceutical statisticians in the development of innovative statistical methodology to build increasingly efficient ophthalmologic clinical trials. Drive analysis and design strategy in ophthalmic industry through membership on strategic guidance committees RESPONSIBILITIES: Research, optimize, and document statistical strategy Explore new measures for target indications with strategy toward reducing time to show efficacy and to increasing differentiability of products Review internal database to determine previous non-primary endpoints that show tendency toward differentiating B L products from competitors Review and coordinate global clinical trial design requirements to build standard strategies, allowing for quicker program development and identification of most efficient global strategy for products and therapeutic areas. Specifically accounting for o Requirements for comparator (active or vehicle, and if active differential active in different regions) o Differential efficacy endpoints by region o Pediatric investigational plans o Serve on due diligence teams assessing design and clinical trial information of external partnership opportunities to evaluate the probability of successful products. o Plan budgets and resources for statistical support of clinical trials. o Establish global statistical strategy accounting for differential requirements of regulatory bodies. o Serve on due diligence team for strategic partnership opportunities. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. * Doctoral degree in statistics (or related field) with 10 years in clinical trials or public health research with at least 4 of those years in the pharmaceutical industry. * Proven ability to multi-task, coordinating different activities to successful completion. * Proven ability to interact with external agencies and personnel to successful outcomes. Job: Research/Development2012-02-27 19:40:31United StatesBausch + LombNew Jersey00007569NJMadison Site, NJ26788077http://bausch.jobs/xml/26788077/jobUSARochester Global Eye Health Center SiteTitle: Statistician Location: United States-New York-Rochester Global Eye Health Center Site The ideal candidate will be able to work independently as the lead statistician on medical device studies of small scope covering varying ophthalmic therapeutic areas, and work collaboratively with other statisticians on projects of medium to large scope. The position will entail applying statistical analysis and interpretation knowledge to conceive and defend efficient study designs and analysis strategies. The ideal candidate will contribute to cross functional study teams and lead SAS programmers to produce the required statistical output. Specific Job Duties • Collaborate on protocol development including the design of the study, clarification of endpoints to meet objectives, calculation of power and sample size, and writing statistical sections. • Review of case report forms, annotations, and edit checks to ensure capturing of all required data in a way that supports a high quality database for the planned analyses. • Creation of randomization strategies and schedules. • Writing and overseeing implementation of statistical analysis plans for multiple studies, creating summary templates and specifications. Support programming of summaries as necessary. • Writing/reviewing statistical and outcome sections of study reports and submissions. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.• PhD in statistics or biostatistics with 0-2 years of experience or MS with 3-4 years of experience in applied statistics, preferably clinical trial experience. • Must have sound working knowledge of statistical theory and application including experimental design, categorical data analysis, linear models, non-parametric methods. Experience with group sequential methods and/or analysis of correlated data preferred. SAS programming in a clinical environment. Proficiency in Base SAS and SAS stat modules. • Excellent verbal and written communication skills, and project management experience preferred. Managerial Responsibility None Job: Research/Development2011-09-01 23:59:37United StatesBausch + LombNew York00007204NYRochester Global Eye Health Center Site, NY23390400http://bausch.jobs/xml/23390400/jobUSARochester Global Eye Health Center SiteTitle: Senior Statistician Location: United States-New York-Rochester Global Eye Health Center Site The ideal candidate will be able to work independently as the lead statistician on multiple medical device studies covering varying ophthalmic therapeutic areas. The position will entail applying statistical analysis and design knowledge (including accounting for correlation within a subject) andclinicaltrial experience to conceive and defend efficient study designs and analysis strategies. The ideal candidate is expected to be the primary statistical representative for high functioning cross functional study teams, being prepared to defend the chosen design and analysis strategies and be flexible enough to understand requests and how the chosen designs account for the requests. Specific Job Duties * Collaborate on protocol development including the design of the study, clarification of endpoints to meet objectives, calculation of power and sample size, and writing statistical sections. * Review of case report forms, annotations, and edit checks to ensure capturing of all required data in a way that supports a high quality database for the planned analyses. * Creation of randomization strategies and schedules. * Writing and overseeing implementation of statistical analysis plans for multiple studies, creating summary templates and specifications. Support programming of summaries as necessary. * Writing/reviewing statistical and outcome sections of study reports and submissions. * Assess feasibility of analysis requests and associated timelines. Communicate/discuss data/analysis issues with team of programmers (SAS and Data Management), statisticians, and clinical managers. · Serve as technical resource to multiple study teams. Develop and present new methods/techniques to team. · Assist with process improvements and in building efficiencies across studies. · Assist in defending strategy and findings to FDA. Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. · PhD in statistics or biostatistics with 2 years of experience or MS with 4 years of experience in applied statistics, preferably clinical trial experience. · Demonstrated ability to lead multiple projects in a fast paced environment. · Must have sound working knowledge of statistical theory and application including experimental design, categorical data analysis, linear models, non-parametric methods. Experience with group sequential methods and/or analysis of correlated data preferred. SAS programming in a clinical environment. Proficiency in Base SAS and SAS stat modules. Job: Research/Development2011-08-29 22:24:00United StatesBausch + LombNew York00007198NYRochester Global Eye Health Center Site, NY23315075http://bausch.jobs/xml/23315075/jobUSARochester Global Eye Health Center SiteTitle: Principal Scientist - Toxicology Location: United States-New York-Rochester Global Eye Health Center SiteThe Toxicologist hired for this technical position will be responsible for the strategy development, execution and management of Non-Clinical Safety programs focused on Bausch and Lomb Pharmaceutical and Vision Care product development Independently design and interpret GLP and non-GLP Safety Studies using applicable Regulatory Guidance documents Execute study placement and monitor activities of CROs performing toxicology studies Serve as representative on project teams Organize, track and integrate safety data and present results to project teams, management and for external presentations/publications Conduct Risk assessments of new materialsEducation: PhD or MS in Toxicology preferred Experience: At least 10 yrs experience in Toxicology with Industrial experience preferred. Knowledge/experience of Pharmaceutical and or Medical Device Toxicology Special Skills: Successful candidate will possess strong critical thinking abilities, and be team-oriented with excellent verbal and written communication skills. Computer skills should be robust and include Microsoft Word, Excel, and Power Point. Job: Research/Development2011-08-29 22:23:57United StatesBausch + LombNew York00007153NYRochester Global Eye Health Center Site, NY23315074http://bausch.jobs/xml/23315074/job