Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics

Merck • Upper Gwynedd Township, PA

1d • $173,200 - $272,600

About The Position

As part of the Manufacturing Division, the Sterile Drug Product Commercialization group provides technical process leadership and laboratory capabilities for late-stage and commercial biologic drug product processes. 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 of significant manufacturing investigations.

The Principal Scientist advances and commercializes biologics pipeline programs as a member of the drug product team, with a focus on process characterization, scale-up, transfer, and process validation. The role provides technical leadership across development and commercialization, supports regulatory filing through launch and post-launch, and guides employees on complex scientific and technical matters. It also drives continuous improvement, innovation, and the development of standardized commercial platforms for liquid, lyophilized, and combination-product presentations.

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or a related field and 12 years of relevant experience; or a master’s degree in one of these fields and 10 years of relevant experience; or a Ph.D. in one of these fields and 8 years of relevant experience.
• Experience with drug product process development, optimization, and/or process characterization for biologics such as monoclonal antibodies, antibody-drug conjugates, and/or fusion proteins.
• Experience with at-scale biologics drug product manufacturing and fill-finish operations.
• Experience with late-stage commercialization of biologics programs.
• 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.
• Excellent oral and written communication skills, including the ability to articulate process-science understanding to drive decisions, impact assessments, and study design in multidisciplinary teams.

Nice To Haves

• Operations experience manufacturing potent and sterile drug products at pilot and/or commercial scale.
• Experience commercializing biologics programs through PPQ and launch.
• Working knowledge of analytical methods and product attributes for biologics.
• 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 DOE design and data analysis, statistical process control, multivariate analysis, and/or process analytical technology techniques for manufacturing processes.
• Experience in data analytics, computer modeling, and digital applications.
• Working understanding of analytical methods used to characterize biologics and other sterile drug products.

Responsibilities

• Execute and provide oversight for biologics product and process design, development, characterization, technology transfer, and commercial validation.
• Lead or participate in 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, 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 technical and business-process initiatives within the department and with partner groups to enable more efficient commercialization of innovative products.
• Mentor employees and provide technical oversight and strategic guidance, using advanced scientific and technical experience to help resolve non-routine or difficult issues.
• Develop process and product development plans and influence decisions related to primary packaging and combination-product design.
• 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, and 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 strategies, 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 and phase-appropriate process optimization toward standardized platforms for liquid, lyophilized, and combination-product presentations.
• Establish and foster a culture of high performance, innovation, learning, empowerment, and out-of-the-box thinking.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• 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: Principal