Associate Principal Scientist, Vaccine Sterile DP

MSD; Upper Gwynedd Township (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

MSD is seeking an Associate Principal Scientist to advance biologics pipeline programs within the Vaccine, Sterile Drug Product Commercialization group. The role focuses on process characterization, scale-up, and regulatory-aligned development for late-stage and commercial products.

You will lead cross-functional DP activities through registration, PPQ readiness, tech transfer, and process validation, while mentoring colleagues and advancing scalable platform methods in a hybrid U.S.

Qualifications

• Experience with vaccine product development, scale-up, and regulatory filings.
• Knowledge of cGMPs for sterile dosage forms and ICH quality norms.
• Experience with technology transfer and process validation at commercial sites.

Responsibilities

• Leads cross-functional DP teams to support vaccine programs.
• Drives DP development, process validation, and tech transfer activities.
• Authors and reviews regulatory submissions, and supports pre-approval activities.
• Mentors staff and provides strategic guidance on complex issues.
• Develops fit-for-purpose scale-down models and platform engineering.

Skills

Process characterization

Scale-up

Tech transfer

PPQ readiness

Regulatory strategy

Sterile drug product

Leadership

Cross-functional collaboration

Education

Ph.D. or MS with relevant experience in chemical/biochemical field

Experience in GMP sterile manufacturing

Job description

MSD is seeking an Associate Principal Scientist to advance biologics pipeline programs within the Vaccine, Sterile Drug Product Commercialization group. The role focuses on process characterization, scale-up, and regulatory-aligned development for late-stage and commercial products.

You will lead cross-functional DP activities through registration, PPQ readiness, tech transfer, and process validation, while mentoring colleagues and advancing scalable platform methods in a hybrid U.S.