Principal Scientist (ADC), Sterile Drug Product Commercialization

Merck KGaA Darmstadt Germany • Rahway, NJ

410d • $164,800 - $259,400 • Onsite

About The Position

The Principal Scientist in the Sterile Drug Product Commercialization group will lead the technical process development and commercialization of antibody-drug conjugates (ADCs). This role focuses on driving excellence in process characterization, scale-up, technology transfer, and validation activities for ADC products, ensuring compliance with regulatory requirements and fostering a culture of innovation and high performance within the team.

Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or Master's degree with 10 years; or Ph.D. with 8 years of relevant experience.
• Experience with drug product process development, optimization, and/or process characterization of ADCs.
• Experience with at scale ADC drug product manufacturing and fill finish operations.
• Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules.
• Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
• Excellent oral and written communication skills.

Nice To Haves

• Experience in ADC and biologics drug product fill finish process optimization, scale-up and technology transfer.
• Experience with commercialization of ADC programs through PPQ and launch.
• Working knowledge in analytical methods and product attributes for ADCs.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products.
• Experience in Data Analytics, Computer Modeling, and Digital Applications.

Responsibilities

• Execute and provide oversight to ADC product and process design, development, characterization, technology transfer, and robust commercial validation.
• Lead and/or serve on cross-functional ADC drug product working groups and manage DP activities through filing and Process Performance Qualification (PPQ).
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Drive strategic initiatives in the department and with partner groups for efficient commercialization of innovative products.
• Provide mentorship, technical oversight, and strategic guidance to employees.
• Develop a process and product development plan and influence decisions related to primary packaging and combination product design.
• Design and execute DP development and commercialization studies, new product introduction, and process validation at commercial sites.
• Establish and validate platform engineering and scientific models for sterile product and process commercialization.
• Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
• Influence CMC regulatory strategy and be accountable for DP CMC sections of filing.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree