Associate Principal Scientist, Sterile Drug Product Commercialization

Merck • Upper Gwynedd Township, PA

3d • $142,400 - $224,100 • Onsite

About The Position

As part of the Manufacturing Division’s Sterile Drug Product Commercialization group, this role provides technical leadership for late-stage and commercial drug product processes for biologics and combination products. The group leads sterile product and process development, including process scale-up, technology transfer to internal and external sites, process validation, regulatory submissions, and support for significant manufacturing investigations.

The Associate Principal Scientist is a member of the biologics drug product team and leads work to advance and commercialize biologics programs. The role focuses on process characterization, scale-up, technology transfer, and process validation, while guiding development and commercialization activities from filing and process qualification through launch and post-launch support. It also provides technical oversight and mentorship, influences regulatory and product design strategies, and drives process optimization and commercialization best practices.

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or a related field with 10 years of relevant experience; or a master’s degree in one of these fields with 8 years; or a Ph.D. in one of these fields with 4 years.
• Experience with drug product process development, optimization, and/or process characterization of biologics.
• Experience with at-scale biologics drug product manufacturing and fill-finish operations.
• Technical expertise in sterile drug product fill-finish manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
• Experience transferring and scaling processes to pilot and/or manufacturing scales.
• Experience optimizing, scaling up, and transferring biologics drug product fill-finish processes for sterile products to pilot or commercial operations.
• Excellent oral and written communication skills, including the ability to articulate process science to support decision-making, impact assessments, and study design in multidisciplinary teams.
• Required skills listed: bioprocessing, commercialization, decision-making, drug product manufacturing, leadership, manufacturing process validation, manufacturing scale-up, process improvements, product commercialization, protein purifications, regulatory submissions, technical transfer, technical writing, and technology transfer.

Nice To Haves

• Operations experience manufacturing potent and sterile drug products at pilot and/or commercial scale.
• Experience with late-stage commercialization of biologics programs.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including Quality by Design principles.
• Working knowledge of current Good Manufacturing Practices for sterile dosage-form manufacturing and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations.
• Working knowledge of statistical methods for design of experiments and data analysis, statistical process control, multivariate analysis, and/or process analytical technologies for manufacturing processes.
• Experience in data analytics, computer modeling, and digital applications such as 3-D printing.
• Working understanding of analytical methods for characterizing biologics and other sterile drug products.

Responsibilities

• Lead or serve on cross-functional biologics drug product working groups and manage drug product activities through filing and Process Performance Qualification (PPQ), including registration stability studies, process characterization planning and execution, technology transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection readiness, approval, launch, and post-launch support.
• Ensure commercialization programs meet requirements for science, quality, reliability, schedule, and cost.
• Drive strategic technical and business-process initiatives with department and partner groups to enable efficient commercialization of innovative products.
• Mentor employees and provide technical oversight and strategic guidance on scientific and technical issues, including difficult or non-routine issues.
• Develop process and product development plans and influence primary packaging and combination product design decisions.
• Design and execute drug product development and commercialization studies, new product introduction, and process validation at commercial sites.
• Ensure fit-for-purpose scale-down models are developed and used; establish and validate platform engineering and scientific models for sterile product and process commercialization.
• Develop best practices for commercial-site technology transfer, facility fit, and drug product control strategy, including classification of process and performance parameters, operating ranges, and in-process controls.
• Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
• Influence CMC regulatory strategy; take accountability for drug product CMC filing sections; review regulatory strategy and filing readiness; support agency-meeting preparations; and author and review regulatory submissions.
• Drive continuous, phase-appropriate process optimization toward standardized platforms for liquid, lyophilized, and combination product presentations.
• Foster a culture of high performance, innovation, learning, empowerment, and unconventional thinking.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior