Associate Principal Scientist, Engineering

$135,500 - $213,400/Yr

Merck & Co. - West Point, PA

Full-time - Senior

Onsite - West Point, PA

Chemical Manufacturing

About the position

The Associate Principal Scientist in the Sterile Drug Product Commercialization (SDPC) group will lead the technical process development and commercialization of intravitreal (IVT) pipeline products. This role involves overseeing late-stage product development, managing activities through regulatory filing, and ensuring successful technology transfer to commercial manufacturing sites. The position requires a strong focus on developing scalable manufacturing processes and providing technical guidance to ensure compliance with regulatory standards.

Responsibilities

• Provide technical guidance and oversight of late-stage product and process development.
• Manage drug product activities through filing and Process Performance Qualification (PPQ).
• Develop robust and scalable manufacturing processes while minimizing time to regulatory filing and product launch.
• Design and execute drug product development and commercialization studies at commercial sites.
• Drive the design and execution of process characterization activities.
• Ensure fit-for-purpose scale-down models are developed and employed.
• Oversee lab studies to ensure 'right first time' outcomes.
• Apply technical knowledge to design experiments that contribute to departmental goals.
• Guide others in addressing non-routine and difficult scientific/technical issues.
• Manage commercial site technology transfer and facility fit.
• Influence primary packaging decisions and drive process demonstration and qualification strategy.
• Review regulatory strategy and support preparations for agency meetings.
• Author and review regulatory filings.
• Establish and validate platform engineering and scientific models for commercialization.
• Monitor performance and recommend schedule changes, cost adjustments, or resource additions.
• Provide regular summaries of progress against development plans and key program risks.
• Serve on cross-functional teams and support strategic initiatives.
• Lead implementation of new/improved business processes in partnership with colleagues.
• Drive continuous process optimization towards standardized platforms for various product presentations.
• Provide mentorship and strategic guidance to employees.

Requirements

• Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience; OR Master of Science (M.S.) degree with six (6) years of relevant experience; OR Ph.D. with three (3) years of relevant experience.
• Experience in biologics drug product fill finish process optimization and technology transfer of sterile products.
• Knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing sterile dosage forms.
• Experience with Design of Experiment (DoE) and statistical data analysis.
• Excellent interpersonal and communication skills.

Nice-to-haves

• Experience in intravitreal/ophthalmic manufacturing practices.
• Knowledge of single-use system technologies.
• Experience in authoring and reviewing CMC regulatory documentation.
• Project management skills including dashboards and activity trackers.
• Experience in Data Analytics.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days