Principal Scientist, Engineering

$164,800 - $259,400/Yr

Merck & Co. - West Point, PA

Full-time - Senior

Onsite - West Point, PA

Chemical Manufacturing

About the position

The Principal Scientist role within the Sterile Drug Product Commercialization (SDPC) group focuses on advancing and commercializing intravitreal pipeline products. This position involves leading process scale-up, technology transfer, and validation activities at a start-up manufacturing site, ensuring that commercialization programs meet scientific, quality, reliability, schedule, and cost requirements. The role requires collaboration with cross-functional teams and mentorship of junior staff, while also influencing regulatory strategies and authoring submissions.

Responsibilities

• Execute and provide oversight to intravitreal product and process design, development, characterization, technology transfer, and robust commercial validation.
• Serve on cross-functional drug product working groups and support intravitreal drug product activities through filing and Process Performance Qualification (PPQ).
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Provide mentorship, technical oversight, and strategic guidance for intravitreal process optimization.
• Develop a process and product development plan and influence decisions related to primary packaging.
• Innovate and drive best practices for commercial site tech transfer and development of the drug product control strategy.
• Define the classification of process parameters, performance parameters, operating ranges, and in-process controls.
• Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
• Influence CMC regulatory strategy and author drug product CMC sections of filing.
• Review regulatory strategy and filing readiness and support preparation for agency meetings.
• Author and review regulatory submissions.
• Create best practices in process scale down, parameter finding, site characterization, and transfer.
• Establish and foster a culture of high performance, innovation, and inclusion.

Requirements

• Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with ten (10) years of relevant experience; OR Master of Science (M.S.) degree with eight (8) years of relevant experience; OR Ph.D. with five (5) years of relevant experience.
• Comprehensive knowledge and hands-on experience in the development of intravitreal products.
• Experience in intravitreal/ophthalmic manufacturing practices for low particulate, low bioburden/endotoxin environments.
• Experience in sterile drug product fill finish manufacturing practices including low volume fills and small batch scale.
• Experience in biologics drug product fill finish process optimization, scale-up, and technology transfer.
• Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms.
• Excellent oral and written communication skills.
• Ability to effectively articulate understanding of process science in a multi-disciplinary team environment.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products.

Nice-to-haves

• Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
• Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes.
• Experience in Data Analytics and Computer Modeling.
• Working understanding of analytical methods to characterize vaccines, biologics, and other sterile drug products.

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