Principal Scientist, Engineering – Sterile Drug Product Commercialization

About the role

Join the Sterile Drug Product Commercialization group within MSD's Manufacturing Division to lead technical process development and laboratory activities for late‑stage biologics products. The Principal Scientist will drive process characterization, scale‑up, technology transfer and validation for commercial drug‑product manufacturing.

Key responsibilities

• Design, develop and oversee biologics product and process characterization, technology transfer and commercial validation activities.
• Lead cross‑functional drug‑product working groups through filing, Process Performance Qualification (PPQ), registration stability studies and post‑launch support.
• Develop and validate platform engineering models for sterile product and process commercialization, including control strategy and shelf‑life planning.
• Influence CMC regulatory strategy, author DP sections of filings and support agency interactions.

Required profile

• Bachelor’s (12 y), Master’s (10 y) or PhD (8 y) in Chemical/Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology or related field.
• Extensive experience with biologics (mAbs, ADCs, fusion proteins) drug‑product process development, scale‑up and fill‑finish operations.
• Proven track record in late‑stage commercialization, technology transfer and PPQ execution.
• Strong oral and written communication skills to guide multidisciplinary teams.

Required skills

• Sterile drug‑product fill‑finish manufacturing processes for large molecules.
• Technology transfer and scale‑up to pilot/commercial scale.
• cGMP, Quality by Design (QbD) and ICH quality norms.
• Statistical methods: DOE design, SPC, multivariate analysis, PAT.
• Data analytics, computer modeling and digital applications.
• Analytical methods for biologics characterization.