Associate Principal Scientist, Sterile Drug Product Commercialization

Merck • Upper Gwynedd Township, PA

3d • $142,400 - $224,100

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 biologics and combination-product processes. The group leads sterile product and process development, including scale-up, technology transfer to internal and external sites, process validation, regulatory submissions, and support for significant manufacturing investigations.

The Associate Principal Scientist advances and commercializes biologics pipeline programs, with a focus on process characterization, scale-up, transfer, and validation. The role leads or participates in cross-functional drug product teams and manages activities through filing, Process Performance Qualification (PPQ), approval, launch, and post-launch support. It provides technical oversight and mentorship, guides commercialization strategy and execution, and contributes to regulatory filings and continuous process optimization.

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 of relevant experience; or a Ph.D. in one of these fields with 4 years of relevant experience.
• 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, including sterile products to pilot or commercial scale.
• Excellent oral and written communication skills and the ability to explain process science to support decision-making, impact assessments, and study design in multidisciplinary teams.

Nice To Haves

• Operations experience in 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 design 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 and/or participate in cross-functional biologics drug product working groups and manage drug product activities through filing and PPQ, including registration stability studies, process characterization, technology-transfer control strategy, process development, PPQ and 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 that enable more efficient commercialization of innovative products.
• Mentor employees and provide technical oversight and strategic guidance, particularly on non-routine or difficult scientific and technical 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.
• Advance best practices for commercial-site technology transfer, facility fit, and drug product control-strategy development, 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; own drug product CMC filing sections; review regulatory strategy and filing readiness; support agency-meeting preparation; 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, vision, healthcare, and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

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