Principal Scientist, Engineering

$164,800 - $259,400/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The 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 focuses on driving excellence in process scale-up, technology transfer, and validation activities at a start-up manufacturing site, ensuring compliance with regulatory standards and quality requirements.

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's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with ten years of relevant experience; OR a Master's degree with eight years of relevant experience; OR a Ph.D. with five years of relevant experience.
• Comprehensive knowledge and hands-on experience in the development of intravitreal products.
• Experience in sterile drug product fill finish manufacturing practices, including low volume fills and small batch scale.
• Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms.
• Excellent oral and written communication skills, with the ability to articulate 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 in biologics drug product fill finish process optimization and technology transfer.
• Knowledge of statistical methods for DOE design and data analysis, SPC, MVA, and/or PAT techniques for manufacturing processes.
• Experience in Data Analytics and Computer Modeling.

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