Technical Lead for Pharmaceutical and Medical Device Products

7 days ago


Rochester, New York, United States Bausch + Lomb Full time
Job Summary

Bausch + Lomb, a leading global eye health company, is seeking a highly skilled Principal Scientist to provide technical leadership to our Pharmaceutical and Medical Device Products portfolio. This role will be responsible for ensuring the continuity of supply, product transfers, geographic expansion, and new business development.

Key Responsibilities
  • Develop and implement technical transfer strategies for GMP activities at Contract Manufacturing Organizations (CMOs) across functional organizations.
  • Ensure project plans meet technical, regulatory, and GMP standards, and support risk assessments and troubleshooting activities to address out-of-specification events.
  • Provide product stewardship and oversight of high-revenue products to monitor performance trend data.
  • 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.
  • Apply statistical process control and lean six-sigma practices to validation strategies and product knowledge.
  • Ensure externally sourced products are scientifically robust, manufactured under control, and remain in a constant state of validation throughout their product lifecycle to maintain a consistent supply of quality, safe, and effective products to patients.
Requirements
  • Bachelor's degree (BS) in a scientific discipline (Chemistry, Biology, Microbiology, Pharmacy, or related field) with 10 years of relevant experience, or a graduate degree plus 5 years of 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).
Equal Employment Opportunity

Bausch + Lomb is an equal opportunity employer and welcomes applications from diverse candidates. 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.



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