This role pays less than
57%
of similar roles. Most pay
$160,943–$235,750
— the shaded band above.
At the midpoint, this role pays about
$183k
versus about
$198k
for comparable roles.
Based on 240 similar postings.
Employer
About MSD
MSD (Merck Sharp & Dohme) is the international name for Merck & Co., a major U.S.-based pharmaceutical company.
MSD currently has
25 open roles
on FindRole.
Listed pay typically runs
$117,000–$184,200
across 25 roles with salary data.
Associate Principal Scientist, Engineering - Vaccine, Sterile Drug Product Commercialization joins the Manufacturing Division’s Sterile Drug Product Commercialization group to provide technical leadership for late-stage and commercial drug product processes. This role focuses on advancing a biologics pipeline by driving excellence in process characterization, scale-up, technology transfer, and process validation. The successful candidate will lead cross-functional working groups, manage registration stability studies, oversee Pre-Approval Inspection readiness, and author regulatory submissions for sterile products. Key responsibilities include developing fit-for-purpose scale-down models and optimizing processes for liquid, lyophilized, and combination products. Required expertise includes drug product manufacturing, fill finish operations, and knowledge of cGMPs and ICH Quality norms. The role requires proficiency in statistical methods like DOE, SPC, and MVA, alongside skills in biochemistry, bioprocess engineering, and technical writing to solve complex challenges in vaccine and sterile pharmaceutical commercialization.
Lead cross-functional working groups to support early and late pipeline vaccine drug product programs.
Manage drug product activities through filing, process performance qualification (PPQ), and pre-approval inspection (PAI) readiness.
Execute process characterization, scale-up, technology transfer, and validation for sterile products at commercial sites.
Develop and implement fit-for-purpose scale-down models and validated platform engineering models.
Influence CMC regulatory strategy and author the drug product sections of regulatory submissions.
Drive continuous process optimization toward standardized platforms for liquid, lyophilized, and combination products.
Provide technical oversight, mentorship, and strategic guidance to team members on complex scientific issues.
What we're looking for
A B.S. degree with 10 years of experience, a Master's with 8 years, or a Ph.D. with 4 years is required in a relevant engineering or science field.
Experience in drug product process development, optimization, and characterization for vaccine modalities is required.
Knowledge of cGMPs for manufacturing sterile dosage forms and ICH Quality norms is required.
Understanding of regulatory requirements for commercialization and registration of sterile drug products, including Quality by Design principles, is required.
Technical expertise in sterile drug product fill finish processes for large molecules and experience with technology transfer to pilot or manufacturing scales are required.
Excellent oral and written communication skills to articulate process science and drive decision making in multi-disciplinary teams are required.
Experience in the manufacturing of potent and sterile drug products at pilot or commercial scale is preferred.
Working knowledge of statistical methods for DOE, SPC, MVA, and PAT techniques, as well as experience in data analytics and modeling, is preferred.
Antibody Drug Conjugates (ADC)
Bioconjugation
Conjugation Chemistry
Chromatographic Techniques
Bioreactors
cGMP
GMP
Process Development
Process Characterization
Process Scale Up
Design of Experiments (DOE)
Root Cause Analysis
Technology Transfer
Capital Project Management
SAP
Procal
Maximo
QlikSense
Spotfire
Process Development
Scale-up
Technology Transfer
cGMP
GDocP
Design of Experiments
Process Modeling
Organic Chemical Synthesis
Wet Chemistry
Process Analytical Technologies (PAT)
Chemical Engineering
Drug Delivery Systems
Combination Products
Process Development
scale up manufacturing
Design Verification
Design Validation
Technical Writing
SOPs
ISO Standards
Material Characterization
Project Management