This role pays less than
68%
of similar roles. Most pay
$140,600–$222,425
— the shaded band above.
At the midpoint, this role pays about
$151k
versus about
$182k
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
15 open roles
on FindRole.
Listed pay typically runs
$117,000–$184,200
across 15 roles with salary data.
Sr. Scientist, Engineering joins the Sterile Drug Product Commercialization group to provide technical leadership for late-stage and commercial drug product processes involving vaccines, biologics, and sterile pharmaceuticals. The role involves leading drug product science to establish and execute commercial process development studies for targeted biologics pipeline programs. Key responsibilities include designing and executing studies to characterize sterile drug product processes, developing robust and scalable manufacturing processes, and managing technology transfers to manufacturing sites. The candidate will utilize Design of Experiments (DOE), statistical tools, and Quality by Design (QbD) principles while authoring technical protocols and CMC regulatory submissions. Required expertise includes experience in large biological molecules, process optimization, and scale-up for liquid, lyophilized, or combination products. Essential skills include knowledge of cGMP regulations, chromatography, and project management to ensure high-quality manufacturing science and technical operations.
Design and execute studies to develop and characterize sterile drug product processes and integrated control strategies.
Develop and transfer robust, scalable manufacturing processes to commercial production sites while minimizing time to launch.
Establish the technical framework and strategy for process validation at commercial manufacturing sites.
Manage drug product activities for inline and pipeline programs, including lifecycle management and regulatory filings.
Utilize Design of Experiments (DOE) and scale-down models to optimize process development and ensure robust results.
Author technical protocols, reports, and high-quality CMC sections for regulatory submissions.
Develop and validate platform engineering and scientific models for sterile product commercialization.
Drive continuous process optimization toward standardized platforms for liquid, lyophilized, and combination products.
What we're looking for
A Bachelor of Science in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or a related field is required.
Candidates must have experience with a B.S., with an M.S., or a Ph.D. with no industry experience.
Experience must include laboratory drug product process development, scale-up, and technology transfer for sterile products.
Experience in the manufacturing of large biological molecules and understanding of protein attributes is required.
Candidates must have working knowledge of cGMP for sterile dosage forms and ICH Quality norms.
Experience with Quality by Design (QbD) principles and authoring/reviewing CMC regulatory documentation is preferred.
Proficiency in technical writing, problem-solving, and project management tools like dashboards or activity trackers is required.
Ability to travel up to 25% for the role is required.
Remote (West Point, PA)8 days ago
$117,000–$184,200
Biologics
Cell Culture
cGMP
Process Development
Upstream Processing
Design of Experiments (DOE)
Technology Transfer
Mammalian Cell Culture
Chromatographic Techniques
Quality by Design (QbD)
Lean Six Sigma
Regulatory Submissions
IND
MAA
BLA
Statistical Data Analysis
Remote (West Point, PA)9 days ago
$173,200–$272,600
Bioprocess Engineering
Upstream Cell Culture
Process Development
Technology Transfer
cGMP
Process Characterization
Scale-up
Validation
Antibody Therapeutics
Viral Clearance
Process Performance Qualification (PPQ)
Analytical Characterization
Product Development Lifecycle
Clinical Manufacturing
CHO Cell Culture
Bioreactor Perfusion
Process Analytical Technology (PAT)
Design of Experiments (DOE)
Cell Metabolic Modeling
Machine Learning
AMBR
cGMP
Protein Characterization
scale up
scale down
Shake Flasks
Process Engineering
Chemical Engineering
Python
MATLAB
C++
COMSOL
Scale-Up Suite
M-Star
cGMP
Process Analytical Technology (PAT)
Flow Chemistry
Unit Operations
Distillation
Crystallization
Process Safety
Technical Transfer
Automation