Principal Scientist, Sterile Biologics Commercialization

Merck; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck, located in West Point, PA, seeks an experienced Principal Scientist to advance and commercialize biologics processes across late-stage and commercial programs. You will lead process characterization, scale-up, tech transfer, and process validation for sterile drug products in a fast-paced manufacturing division.

Responsibilities include coordinating DP development, PPQ readiness, and regulatory submissions, while mentoring teams and driving best practices for commercialization at global

Qualifications

• Experience with drug product process development, optimization, and/or process characterization of biologics (mAbs, ADCs and/or fusion proteins)
• Experience with at scale biologics drug product manufacturing and fill finish operations
• Experience with late-stage commercialization of biologics programs
• 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.

Responsibilities

• Execute and provide oversight to biologics product and process design, development, characterization, technology transfer, and robust commercial validation
• Leads cross-functional biologics DP teams through filing and PPQ readiness, including stability and PPQ readiness
• Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements
• Drive strategic initiatives to enable faster commercialization of innovative products
• Mentor team members and provide technical guidance on complex issues
• Develop development plans influencing packaging and product design
• Oversee DP development and commercialization studies at commercial sites
• Establish platform models for sterile product and process commercialization
• Drive best practices for tech transfer and process qualification
• Support regulatory submissions and CMC strategy for filings

Skills

Biologics process development

Scale-up & tech transfer

Process characterization

Late-stage commercialization

Sterile drug product manufacturing

Regulatory strategy & filing

PPQ readiness

Effective communication

Education

B.S. in Chemical Engineering

M.S. in Chemical Engineering

Ph.D. in Chemical Engineering

Job description

Merck, located in West Point, PA, seeks an experienced Principal Scientist to advance and commercialize biologics processes across late-stage and commercial programs. You will lead process characterization, scale-up, tech transfer, and process validation for sterile drug products in a fast-paced manufacturing division.

Responsibilities include coordinating DP development, PPQ readiness, and regulatory submissions, while mentoring teams and driving best practices for commercialization at global