Associate Scientist Engineering
About The Position
The Associate Scientist will join the Vaccines team within Sterile Drug Product Commercialization (SDPC), part of the manufacturing division. SDPC provides technical process leadership and laboratory capabilities for late-stage and commercial drug product processes involving vaccines, biologics, and sterile pharmaceutical products. Its commercialization work includes process development and scale-up, technology transfer to internal and external sites, process validation, regulatory submission authoring, and support for significant manufacturing investigations. The group establishes the science, engineering, and knowledge needed to commercialize novel products. The role supports drug product (DP) commercialization from process development through Process Performance Qualification (PPQ), regulatory filing, launch, and post-launch. It designs, authors, and executes commercialization studies and technical documents, contributes to scale-down models and control strategies, and helps ensure programs meet scientific, quality, reliability, safety, schedule, and cost requirements. The position is based in West Point, Pennsylvania, requires onsite work four days per week, and is listed as hybrid with a first-shift schedule. Travel is required; the posting gives both up to 10% in the role description and 25% in the travel requirements section.
Requirements
- B.S. or higher degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or a related field.
- Excellent oral and written communication skills.
- Ability to articulate an understanding of process science to drive decision-making in a multidisciplinary team environment.
- Ability to travel for the position; the description states up to 10% travel, while the job details list 25%.
Nice To Haves
- Technical experience in large-molecule drug product process characterization, fill-finish process optimization, scale-up, and technology transfer of sterile products to pilot or commercial settings.
- Knowledge of combination product development.
- Working knowledge of regulatory requirements or current Good Manufacturing Practices (cGMPs) 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 (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) for manufacturing processes.
- Working understanding of analytical methods to characterize vaccines and other sterile drug products.
- Adaptability, data analysis, experimentation, laboratory techniques, manufacturing, process capability analysis, process definition, process design, process development, process engineering, product formulation, statistical data analysis, technical reviews, technical writing, technology transfer, timeline management, and writing technical documents.
Responsibilities
- Support cross-functional DP working groups from process development through PPQ and regulatory filing, including registration stability studies, process characterization, technology transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection support, launch, and post-launch support.
- Design, author, and execute DP commercialization studies.
- Develop and author technical documents covering process design, definition, qualification, and validation.
- Contribute to development of fit-for-purpose scale-down models.
- Ensure commercialization programs meet requirements related to science, quality, reliability, safety, schedule, and cost.
- Innovate and promote best practices for commercial site technology transfer, facility fit, and DP control strategy development, including classification of process parameters, performance parameters, operating ranges, and in-process controls.
- Manage project work to meet due dates, escalating when necessary and developing remediation plans.
- Contribute to a culture of safety, high performance, innovation, continuous learning, empowerment, diversity, and inclusion.
- Travel as required for the position. The description states up to 10% travel, while the job details list 25%.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
