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Principal Scientist, Engineering
Merck KGaA Darmstadt Germany - Rahway, NJ
posted 2 months ago
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 also includes providing mentorship and strategic guidance, influencing regulatory strategies, and fostering a culture of innovation and inclusion.
Responsibilities
- Execute and oversee intravitreal product and process design, development, characterization, technology transfer, and commercial validation.
- Serve on cross-functional drug product working groups and support intravitreal 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, influencing decisions related to primary packaging.
- Innovate and drive best practices for commercial site tech transfer and development of the DP control strategy.
- Define classification of process parameters, performance parameters, and in-process controls.
- Drive process demonstration and qualification (PPQ) and shelf-life strategies.
- Influence CMC regulatory strategy and author DP CMC sections of filing.
- Review regulatory strategy and filing readiness, supporting preparation for agency meetings.
- Author and review regulatory submissions.
- Create best practices in process scale down, parameter finding, site characterization, and transfer.
- Establish 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 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 sterile dosage forms and current ICH Quality norms.
- Excellent oral and written communication skills.
- Ability to articulate understanding of process science in a multi-disciplinary team environment.
- Working knowledge of regulatory requirements for commercialization of sterile drug products, including Quality by Design principles.
- Working knowledge of statistical methods for DOE design and data analysis.
Nice-to-haves
- 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
