Merck · 21 hours ago
Associate Principal Scientist, Engineering- Biologics, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point
Full-time
Onsite
Senior Level, Lead/Staff
$142K/yr - $224K/yr
8+ years expMerck is a leading company in the pharmaceutical industry, and they are seeking an experienced Associate Principal Scientist in their Sterile Drug Product Commercialization group. The role focuses on driving excellence in process characterization, scale-up, transfer, and process validation activities for biologics and sterile drug products.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Leads and/or serves on cross functional biologics drug product (DP) working groups and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support
Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost
Drives strategic initiatives (technical and/or business process related) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products
Provides mentorship, technical oversight and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues
Develops a process and product development plan. Influences decisions related to primary packaging and combination product design
Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites
Ensures fit-for-purpose scale-down models are developed and employed. Establishes and validates platform engineering and scientific models for sterile product and process commercialization
Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, in-process controls. Drives and influences process demonstration and qualification (PPQ) and shelf-life strategies
Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions
Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations
Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion
Qualification
Required
B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or
Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience
Experience with drug product process development, optimization, and/or process characterization of biologics
Experience with at scale biologics drug product manufacturing and fill finish operations
Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations
Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales
Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment
Preferred
Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial
Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale
Experience with late-stage commercialization of biologics programs
Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations
Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing)
Working understanding of analytical methods to characterize biologics and other sterile drug products
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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2026-01-22
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