Associate Principal Scientist, Sterile Drug Product Commercialization

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Associate Principal Scientist in the Sterile Drug Product Commercialization (SDPC) group is responsible for leading the commercialization of sterile drug products, particularly large molecules. This role involves technical guidance, oversight of product and process characterization, and managing activities through various stages of commercialization, including technology transfer and regulatory submissions. The position requires collaboration with cross-functional teams to ensure successful product development and adherence to regulatory standards.

Responsibilities

• Lead the SDPC Drug Product Working Group for commercialization of sterile drug products.
• Provide technical guidance and oversight for late-stage product and process characterization.
• Manage drug product activities through filing and Process Performance Qualification (PPQ).
• Develop and execute drug product characterization and commercialization studies.
• Design and oversee robust and scalable manufacturing processes.
• Establish and validate platform engineering and scientific models for commercialization.
• Influence CMC regulatory strategy and author regulatory filings.
• Drive continuous improvement and optimization of processes.

Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or Master's degree with 8 years; or Ph.D. with 4 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 Quality by Design (QbD) principles in process development.
• Strong analytical problem-solving skills and competency in technical writing.

Nice-to-haves

• Experience with single-use system technologies.
• Experience in Design of Experiment (DoE) and statistical data analysis.
• Project management skills including dashboards and activity trackers.

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