Senior Principal Scientist – Upstream Biologics Process R&D
| Company | Merck |
|---|---|
| Location | Linden, NJ, USA |
| Salary | $164800 – $259400 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Expert or higher |
Requirements
- Ph.D. with 10+ years, MS with 12+ years, or BS with 14+ years of industry experience in Chemical/Biochemical Engineering or a related field.
- Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactor scale-up and scale-down, as well as recent advances, and challenges in the field.
- Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process development.
- Track record of accomplishments in upstream bioprocessing with a history of peer-reviewed publications and presentations. Strong understanding of cell metabolism and biochemical pathways relevant to bioprocessing.
- Knowledge of biologics CMC development.
- Ability to adapt to and prioritize complex objectives under tight timelines in a rapidly changing environment.
- Experience leading internal and external cross-functional, matrixed teams.
- Demonstrated scientific leadership with significant, measurable project impacts across a diverse set of programs.
- Action-oriented mindset with a capacity for creativity; ability to take initiative, innovate, iterate, and solve problems.
- Supervise, coach and mentor scientists to maximize talent development and utilization.
- Excellent interpersonal and communication skills.
Responsibilities
- Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy, and science.
- Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment.
- Lead the development of robust and scalable upstream processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.
- Improve upstream processes by increasing efficiency and cost-effectiveness through research and innovation, while evaluating technologies and industry best practices.
- Collaborate with academia, industry, and vendors to facilitate the development and early adoption of novel process technologies.
- Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.
- Conceptualize, plan, and execute projects using effective organizational, prioritization, and problem-solving skills.
- Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference participation.
- Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.
- Supervise, coach, and develop talent within the functional area; guide career development; build strong, collaborative teams.
- Champion compliance and safety while promoting a culture of diversity, equity, and inclusion.
Preferred Qualifications
- Leadership of CMC development teams.
- Experience with continuous biomanufacturing integrated with process-analytical technologies.
- Intensified inoculum and perfusion process development.
- Expertise in media/solution development and chemistry.
- High-throughput experimentation, automation, and process control.
- Knowledge of microbial fermentation.
- Cell culture predictive modeling (omics (transcriptomics, metabolomics, or/and proteomics), metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence.