Associate Scientist Engineering – Sterile Drug Product Commercialization

About the role

The Associate Scientist will join the Vaccines team within Sterile Drug Product Commercialization, supporting late‑stage and commercial drug‑product processes for vaccines and sterile biologics.

Key responsibilities

• Support cross‑functional DP working groups from process development through Process Performance Qualification (PPQ) and regulatory filing.
• Design, author, and execute DP commercialization studies, including stability, characterization, and technology transfer control strategies.
• Develop technical documents such as process design, qualification, and validation reports.
• Contribute to fit‑for‑purpose scale‑down models and ensure programs meet science, quality, safety, schedule, and cost requirements.
• Manage project timelines, escalating issues and creating remediation plans as needed.

Required profile

• B.S. or higher in Chemical Engineering, Biochemical Engineering, Bio‑engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field.
• Excellent oral and written communication skills with ability to articulate process science in multidisciplinary teams.
• Willingness to travel up to 10% and work on‑site four days per week.

Required skills

• Process development, scale‑up, and technology transfer of sterile drug products.
• Knowledge of cGMP, ICH quality guidelines, and regulatory requirements for sterile dosage forms.
• Statistical methods for DOE design, data analysis, SPC, multivariate analysis, and PAT techniques.
• Understanding of analytical methods for vaccine and sterile product characterization.

What we offer

• Salary range $71,900 – $113,200 per year, with eligibility for annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation, and compassionate/sick days.