Associate Scientist Engineering

Merck • Upper Gwynedd Township, PA

8h • $71,900 - $113,200 • Hybrid

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 submissions, and support for significant manufacturing investigations.

The role supports cross-functional drug product working groups from process development through Process Performance Qualification (PPQ) and regulatory filing. The Associate Scientist designs, authors, and executes commercialization studies and technical documents, contributes to fit-for-purpose scale-down models, and supports the development of process control strategies and transfer to commercial sites. The position is based in West Point, Pennsylvania, is hybrid, and is required to be on-site four days per week. The posting lists travel requirements of 25%; the description also states that travel may be required up to 10%.

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 understanding of process science to drive decision-making in a multidisciplinary team environment.
• Ability to travel for the position.

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 manufacturing sterile dosage forms 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 drug product 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 drug product commercialization studies.
• Develop and author technical documents related to process design, definition, qualification, and validation.
• Contribute to the development of fit-for-purpose scale-down models.
• Ensure commercialization programs meet requirements for science, quality, reliability, safety, schedule, and cost.
• Drive best practices for commercial-site technology transfer, facility fit, and development of the drug product control strategy, including classification of process parameters, performance parameters, operating ranges, and in-process controls.
• Manage project work to meet due dates, escalating issues 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 posting states travel requirements of 25% and separately says travel may be required up to 10%.
• Work on-site four days per week.

Benefits

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

What This Job Offers

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