Associate Principal Scientist, Sterile Drug Product Commercialization

MSD•Upper Gwynedd Township, PA

6d•$142,400 - $224,100•Onsite

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 drug product processes for biologics and combination products. The group leads sterile product and process development and supports late-stage commercialization, including scale-up, technology transfer to internal and external sites, process validation, regulatory submissions, and significant manufacturing investigations. The Associate Principal Scientist will advance and commercialize biologics pipeline programs as a member of the biologics drug product team. The role focuses on process characterization, scale-up, technology transfer, and process validation, and leads or contributes to cross-functional drug product activities through filing, PPQ, approval, launch, and post-launch support. The position also provides technical leadership, mentorship, strategic guidance, and regulatory CMC contributions.

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 biologics drug product process development, optimization, and/or process characterization.
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 sterile biologics drug product fill-finish processes to pilot or commercial settings.
Excellent oral and written communication skills, including the ability to articulate process-science understanding to support decision-making, 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 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 technology techniques.
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, technology-transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection readiness, approval, launch, and post-launch support.
Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements.
Drive strategic technical and business-process initiatives that enable more efficient commercialization.
Provide mentorship, technical oversight, and strategic guidance, including helping employees address non-routine or difficult scientific and technical issues.
Develop process and product development plans and influence decisions on 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 strategy, including classification of process and performance parameters, operating ranges, and in-process controls.
Drive and influence process demonstration, 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 out-of-the-box thinking.