• Principal Scientist

    Bausch + LombRochester, NY 14651

    Job #2640028378

  • Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company 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.

    Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

    Position summary:

    The Principal Scientist - Technical Affairs provides technical leadership to the PMO / Technical Transfer portfolio related to continuity of supply, product transfers, geographic expansion and new business development for pharmaceutical and medical device products. This role will also participate in and provide guidance for significant investigations where product non-conformances are complex.

    Key responsibilities:

    1. Serve as the technical lead (single point of contact) to the PMO / Tech Transfer portfolio.

    2. Develop technical transfer strategy for GMP activities at CMOs working across functional organizations including R&D, QC, QA, Regulatory, Supply Chain, etc.

    3. Ensure project plans adequately address technical Regulatory / GMP standards. Support risk assessments and troubleshooting activities to address out-of-specification (OOS) events.

    4. Provide product stewardship and oversight of high revenue products to monitor performance trend data.

    5. Direct the creation of modern documentation packages for new validations and control and specification limits that are representative of shelf-life limiting measures and critical-to-quality attributes.

    6. Apply statistical process control and lean six-sigma practices to validation strategies and product knowledge.

    7. Ensure externally sourced products are scientifically robust, manufactured under control and remain in a constant state of validation throughout their product lifecycle in order to maintain a consistent supply of quality, safe and effective products to patients.

    Qualifications and experience:

    • Bachelor's degree (BS) in scientific discipline (Chemistry, Biology, Microbiology, Pharmacy or related field) with 10 years relevant experience, or graduate degree plus 5 years relevant experience.

    • Experience in a pharmaceutical or medical device manufacturing environment with technical skills in the manufacturing of solid oral dose, semi-solids, devices, and biologics.

    • Knowledge of GMP regulations and guidelines.

    • Manufacturing process validation experience required.

    • Statistical analysis, JMP or Minitab knowledge a plus (QE tools).

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    As required by New York State's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York State. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For New York State, the range of starting annual base pay for this role is $105,750 - $162,000.

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