Principal Scientist Pharmaceutical Science & Technology

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

Technical Operations is the organization responsible for ensuring Global Manufacturing & Supply continuity for Bausch Healths Rx Generic and Global Expansion Products. Technical Operations utilizes QbD approach to ensure our pharmaceutical 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 safe and effective products to patients .

The Principal Scientist of Pharmaceutical Science and Technology provide proactive support to enable scientific product understanding of chemistry and process.

Responsibilities include :

• Establishing guidelines and processes to support Nitrosamine Risk Assessments for the entire product portfolio within scope of current Nitrosamine working group
• Be responsible for the synthetic chemistry oversight and transfer technology for active pharmaceutical ingredients (APIs) and drug products
• Develop and maintain subject matter expertise in Extractables / Leachables and / or Elemental Impurity Analysis guidelines and requirements
• Provides technical support to R&D during API and drug product manufacturing scale-up process / packaging validation and launch of new products at external manufacturing organizations (EMOs)
• Provides technical research and process knowledge in the implementation of change controls and technical transfers for APIs and drug products
• Monitors process yields reliability robustness and associated stability / shelf-life for trends and triggers for improvement via change control
• In collaboration with Quality supports the accurate execution of routine process change controls process validations and the analysis of Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for APIs and select drug products
• Providing scientific leadership of API and drug product technology transfers to / from external manufacturing sites to ensure right first-time transfers
• Authors technical transfer protocols and reports to support regulatory filings (technical transfers scale-up and post-approval changes)
• Contributes scientific guidance during process / product deviations out-of-trend / out-of-specification (OOT / OOS) investigations for APIs and relevant drug products
• Use scientific and statistical analyses to develop process understanding. Uses knowledge further in root cause analysis investigations
• Provides written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products

Requirements :

The range of starting base pay for this role is 133K-183K. Actual starting pay will be based on a wide range of factors including but not limited to relevant skills experience qualifications education and addition to base pay this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a comprehensive Medical (includes Prescription Drug) Dental Vision Flexible Spending Accounts 401(k) with matching company contribution discretionary time off paid sick time stock purchase plan tuition reimbursement parental leave short-term and long-term disability life insurance accidental death & dismemberment insurance paid holidays employee referral bonuses and employee discounts.

#LI-hybrid

We are an Equal Opportunity Employer. EOE Disability / Veteran. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.

Required Experience :

Staff IC

Key Skills

Machine Learning,Python,Data Science,AI,R,Research Experience,Sensors,Drug Discovery,Research & Development,Natural Language Processing,Data Analysis Skills,Toxicology Experience

Employment Type : Full Time

Experience : years

Vacancy : 1