Global Pharmaceutical Sciences and Technology is the organization responsible for ensuring that internally/externally sourced pharmaceutical 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 safe and effective products to patients.  In the role as Sr. Director of North America/EMEA Pharmaceutical Sciences and Technology you will be responsible for scientists and/or technical professionals engaged in conducting Product Stewardship on Bausch Health top revenue products. You will manage scientists engaged in technical assessments for investigations, root cause analyses and/or manufacturing track-and-trend reviews. You will apply rigorous scientific approaches and strategies to evaluate new commercial product opportunities and in implementing product improvements on legacy products in Bausch Health’s portfolio. You will work cross-functionally to ensure that North America and EMEA manufacturing sites remain at the forefront of contemporary manufacturing science and technologies in all aspects of the finished drug product manufacturing environment. You will also be responsible for leading CMC activities relating to Post Marketing Requirements.

Responsibilities include:

• Leads and coordinates an experienced scientific team in scientific investigations and product process improvements to ensure supply continuity.
• Provides technical support and lends area expertise to R&D during 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.
• Develops strategies and coordinates with Site CMC Operations to maintain a rigorous scientific approach to product lifecycle management.
• 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 complex process change controls, process validations and the analysis of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
• Leads product specific continuous process verification program(s) via the collection, protocol execution and trend analysis of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) at EMOs
• Collecting and analyzing key performance indicators (KPIs) to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
• Providing scientific leadership of technology transfers to/from external manufacturing sites to ensure right first-time transfers. Provides scientific product reviews to direct reports and/or greater audience outside of Pharmaceutical Science & Technology and CMC Site Operations.
• Authors (where applicable) 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 and product complaints.
• Use scientific and statistical analyses (capability/stability) to develop process understanding. Uses knowledge further in root cause analysis investigations. Uses learnings to drive product, process, and scientific improvements.
• Provides written technical justifications for regulatory proposals or regulatory submissions related to externally manufactured products.

Requirements:

• Bachelor’s degree in chemistry, Chemical Engineering, or Pharmaceutical Chemistry with 10+ years of experience, or master’s degree with 8+ years of experience, or Ph.D. with 5+ years of experience in Pharmaceutical Sciences. Experience should include Formulation Development, Technical Transfers, Technical Trouble Shooting and/or Process Optimization.
• CMC Subject Matter Expertise across a broad range of pharmaceutical dosage forms
• Demonstrated industry experience supporting approved commercial products.
• Direct experience with transferring technology and products from R&D to manufacturing.
• Strong trouble shooting skills.
• Must be action oriented, make informed decisions and be self-motivated.
• Working knowledge of databases. Ability to utilize SAS JMP or other statistical analysis software as needed.
• Understanding of CMC regulatory requirements and technical risk management.
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. 
• Ability to detect and resolve problems, own decisions, and accomplish tasks/goals.
• Ability to quickly change priorities and deliver targeted support.
• Ability to present complex scientific information to a business audience.
• Excellent verbal and written communication skills, detail oriented, and ability to work productively in an interdisciplinary team environment.

The range of starting base pay for this role is 203K - 279K.  Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In 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, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts. 

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