Associate Principal Scientist, Engineering- Cell Culture Sciences, Biologics Drug Substance Commercialization

Merck & Co. • Rahway, NJ

218d • $139,600 - $219,700 • Onsite

About The Position

We are seeking a strategic and technical leader with expertise in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions. Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible for leading a team to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.

Requirements

• Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of relevant industry experience OR Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience.
• Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products).
• Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.
• Experience with late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).
• Experience authoring technical documentation in support of process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).
• Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.
• Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
• Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization.
• Excellent interpersonal and communication skills.

Nice To Haves

• Experience in leadership of CMC development teams.
• Experience with cell culture process development for biologics.
• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches related to cell culture and predictive modeling.
• Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support.
• Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles.
• Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).

Responsibilities

• Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.
• Serve as the scientific/technical mentor for junior staff.
• Provide technical guidance in the various aspects of Cell Culture process development/commercialization for large molecule products.
• Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Manage large multifaceted projects as the leader of a cross-functional team.
• Ensure project results meet requirements regarding technical quality, reliability, schedule, and cost.
• Monitor performance and recommend schedule changes, cost adjustments or resource additions.
• Solve technical and non-technical problems throughout the life of the project.
• Provide timely and accurate information and status updates to project sponsors and management.
• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree