Senior Vaccine Process Engineering Lead
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co. is seeking an Associate Principal Scientist to advance and commercialize biologics pipeline programs within the biologics drug product team.
The role focuses on process characterization, scale up, transfer, and process validation for sterile vaccine products across late-stage and commercial programs. You will drive cross-functional program work, partner with early development teams to align product definitions with manufacturing capabilities, and influence regulatory strategy and
Qualifications
- Experience with drug product process development, optimization, and/or process characterization of vaccines modalities.
- Knowledge of cGMPs for sterile dosage forms manufacturing and ICH quality norms.
- Understanding of regulatory requirements for commercialization and filing of sterile drug products, incl. Quality by Design.
- Experience with scale-up, tech transfer to pilot/manufacturing scales, and process validation.
Responsibilities
- Lead cross-functional vaccine drug product (DP) groups to support pipeline programs.
- Ensure commercial product and process definitions align with manufacturing capabilities.
- Drive DP activities through filing, PPQ, stability studies, and regulatory readiness.
Skills
Education
Job description
Merck & Co. is seeking an Associate Principal Scientist to advance and commercialize biologics pipeline programs within the biologics drug product team.
The role focuses on process characterization, scale up, transfer, and process validation for sterile vaccine products across late-stage and commercial programs. You will drive cross-functional program work, partner with early development teams to align product definitions with manufacturing capabilities, and influence regulatory strategy and
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