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

Job Opportunity: Strategic And Technical Leader In Cell Culture Commercialization

The Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department seeks a strategic and technical leader with expertise in cell culture commercialization. The department's primary objective is to provide technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support.

This role involves supporting late-stage and commercial large molecule biologics program activities under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group. The individual will lead 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.

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.
• Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.
• Monitors performance and recommends schedule changes, cost adjustments, or resource additions.
• Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.
• Provides timely and accurate information and status updates to project sponsors and management.
• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Minimum Education Requirement and Experience:

• 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

Required Experience and Skills:

• Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field
• 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 the following: 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

Preferred Experience and Skills:

• 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 e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)
• Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.
• 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).

The salary range for this role is $139,600.00 – $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.