Senior Principal Scientist – Downstream Biologics Process Development
| 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.
- In-depth knowledge and expertise in downstream processing of biologics, biologics CMC development, and the associated challenges.
- Extensive experience in conducting and directing the design, execution, analysis, and documentation of purification process development.
- Proven track record of accomplishments in downstream bioprocessing, including peer-reviewed publications and presentations.
- 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 and coach 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 purification processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.
- Improve downstream 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 downstream 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.
- High-throughput methodologies, experimentation, automation, and process control.
- Knowledge of protein expression, analytics, conjugation chemistry, and formulation.
- Skills with biophysical, mechanistic, and facility modeling; statistical analysis, digitalization, machine learning, and artificial intelligence are a plus.