Lead Scientist, Vaccine Process Commercialization

MSD Malaysia; Northern (KY); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. in West Point, PA, seeks an Associate Principal Scientist for Vaccine, Sterile Drug Product Commercialization. You will lead cross-functional teams in process characterization, scale-up, tech transfer, and regulatory submissions to advance late-stage and commercial vaccine products.

The role requires strong hands-on experience with sterile drug product manufacturing, regulatory filings, and Quality by Design. Travel up to 25% is possible, with a hybrid work arrangement.

Qualifications

• Experience with drug product process development, optimization, and/or process characterization of vaccines.
• Knowledge of current Good Manufacturing Practices (cGMPs) for sterile dosage forms.
• Understanding regulatory requirements for commercialization of sterile drug products (QbD, filing readiness).

Responsibilities

• Lead cross-functional vaccine DP working groups to support pipeline programs.
• Partner with early development vaccine teams to align product and process definitions with manufacturing capabilities.
• Lead DP activities through filing and PPQ, including stability and tech transfer strategies.
• Drive initiatives enabling faster commercialization of innovative products.
• Provide mentorship and strategic guidance on complex technical issues.
• Design and execute DP development studies, introduction of new products, and process validation.
• Develop fit-for-purpose scale-down models and platform engineering for sterile products.
• Influence CMC regulatory strategy and support filings and agency meetings.
• Drive process optimization for liquid, lyophilized, and combination products.

Skills

Process characterization

Tech transfer

Regulatory submissions

cGMP

DOE / data analytics

Scale-up

Regulatory strategy

Vaccine development

Technical writing

Cross-functional leadership

Education

Bachelor's degree in Chemical/Biochemical/Bio-engineering or related field

Master's degree in Chemical/Biochemical/Bio-engineering or related field

Ph.D. in Chemical/Biochemical/Bio-engineering or related field

Job description

Merck & Co. in West Point, PA, seeks an Associate Principal Scientist for Vaccine, Sterile Drug Product Commercialization. You will lead cross-functional teams in process characterization, scale-up, tech transfer, and regulatory submissions to advance late-stage and commercial vaccine products.

The role requires strong hands-on experience with sterile drug product manufacturing, regulatory filings, and Quality by Design. Travel up to 25% is possible, with a hybrid work arrangement.