Principal Scientist (ADC), Sterile Drug Product Commercialization

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Principal Scientist (ADC) role within the Sterile Drug Product Commercialization group is focused on leading the technical process development and commercialization of antibody-drug conjugates (ADCs). This position is responsible for overseeing product and process design, technology transfer, and validation activities, ensuring that commercialization programs meet scientific, quality, and regulatory standards. The role requires collaboration with cross-functional teams and provides mentorship to junior staff, driving strategic initiatives to enhance the efficiency of product development and commercialization.

Responsibilities

• Execute and provide oversight to ADC product and process design, development, characterization, technology transfer, and robust commercialization 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 and rapid commercialization of innovative products.
• Provide mentorship, technical oversight, and strategic guidance to employees.
• Develop a process and product development plan, influencing 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.
• Innovate and drive best practices for commercial site tech transfer and development of the DP control strategy.
• Influence CMC regulatory strategy and be accountable for DP CMC sections of filing, supporting preparations for agency meetings and authoring regulatory submissions.
• Drive continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
• Establish and foster a culture of high performance, innovation, and diversity.

Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or a Master's degree with 10 years of experience; or a Ph.D. with 8 years of 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.
• Experience with late-stage commercialization of ADC programs.
• 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 of sterile products to pilot/commercial scale.
• Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.
• 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.
• Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms.
• Working knowledge of statistical methods for DOE design and data analysis.

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