Associate Principal Scientist, Engineering

$135,500 - $213,400/Yr

Merck & Co. - Rahway, NJ

Full-time - Mid Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Associate Principal Scientist in Engineering will play a crucial role in the Sterile Drug Product Commercialization (SDPC) group within the Manufacturing Division. This position focuses on the technical process leadership and laboratory capabilities for late-stage commercialization of drug products, particularly in the development and manufacturing of vaccines, biologics, and sterile pharmaceutical products. The role involves planning and executing activities related to product design, characterization, and transfer to commercial manufacturing sites, ensuring compliance with regulatory standards and optimizing processes for efficiency and effectiveness.

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.
• Drive the design and execution of process characterization activities.
• Apply technical knowledge to design experiments that contribute to departmental goals.
• Oversee technology transfer and ensure facility fit for commercial sites.
• Influence primary packaging decisions and drive process demonstration and qualification strategy.
• Accountable for drug product CMC sections of regulatory filings and support agency meetings.
• Establish and validate platform engineering and scientific models for commercialization.
• Monitor program performance and recommend adjustments as necessary.
• Provide mentorship and strategic guidance to team members.

Requirements

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; OR
• Master's degree in the same fields with 6 years of relevant experience; OR
• Ph.D. in the same fields with 3 years of relevant experience.
• Experience in biologics drug product fill finish process optimization and technology transfer.
• Knowledge of current Good Manufacturing Practices (cGMPs) for sterile dosage forms.
• Experience with Design of Experiment (DoE) and statistical data analysis.
• Strong analytical problem-solving skills and technical writing competency.

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