Associate Principal Scientist – Sterile Drug Product Commercialization

About the role

Join MSD's Manufacturing Division as an Associate Principal Scientist leading sterile drug product commercialization for biologics and combination products. You will drive process characterization, scale‑up, technology transfer, and validation to bring innovative therapies to market.

Key responsibilities

• Lead cross‑functional biologics drug product teams through filing, Process Performance Qualification (PPQ), and post‑launch support.
• Develop and execute process and product development plans, including primary packaging and combination product design.
• Design and run DP development, commercialization studies, and process validation at commercial sites.
• Establish fit‑for‑purpose scale‑down models and platform engineering for sterile product commercialization.
• Influence CMC regulatory strategy, author DP sections of filings, and support agency meetings.

Required profile

• B.S. with 10 years, M.S. with 8 years, or Ph.D. with 4 years of relevant experience in chemical/biochemical engineering, biopharma, or related fields.
• Proven experience in drug product process development, scale‑up, and technology transfer for biologics.
• Strong oral and written communication skills and ability to mentor technical teams.

Required skills

• Sterile drug product fill‑finish process development and optimization.
• Technology transfer and scale‑up to pilot/commercial scale.
• cGMP, QbD, and ICH quality standards for sterile dosage forms.
• Statistical methods: DOE design, SPC, multivariate analysis, PAT.
• Data analytics, computer modeling, digital applications (e.g., 3‑D printing).