Associate Prin. Scientist – Engineering
| Company | Merck |
|---|---|
| Location | Linden, NJ, USA |
| Salary | $139600 – $219700 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry
- Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry
- Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry
- 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
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
- May be responsible for managing large multifaceted projects as the leader of a cross-functional team
- Champion compliance and safety; promote a culture of diversity, inclusion, and equity
Preferred Qualifications
- Experience in leadership of CMC development teams
- Experience with cell culture process development for both biologics and vaccines
- 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)