The role:Reporting to the Director, Upstream Process Development, the (Associate) Scientist will contribute to upstream viral process development to bring the company's pipeline of T cell and viral vector-based products to the clinic. Responsibilities will include, but are not limited to, performing the day-to-day activities of the viral process development lab, building the company's viral manufacturing capabilities, and executing experiments to support viral process development/characterization. This role will collaborate significantly with research and analytical development teams.
Key responsibilities:- Contribute to the setup and organization of the company's vector process development capabilities.
- Perform day-to-day activities in the vector process development lab including maintaining equipment, ordering materials, managing inventory, and preparing buffers and process aids.
- Serve as a PD subject matter expert on both internal and external teams (CDMO, material & equipment suppliers, etc.).
- Develop bench scale suspension culture processes for viral vector generation within shake flasks and bioreactors.
- Design and execute experiments to support process characterization, and process transfer activities between the research team, TechOps, and external partners.
- Provide experimental execution, data review and analysis, and maintenance of accurate and detailed lab notebooks.
- Author and review technical documents, including but not limited to batch records, SOPs, development reports and process specific sections of regulatory documents.
- Represent the company externally at meetings (professional associations, with regulatory bodies, etc.)
Required experience & skills:- Bachelor's Degree in chemical engineering, biochemical engineering/bioengineering, biotechnology or related discipline with at least 2 years of relevant experience- OR- Master's Degree in relevant discipline
- Hands-on experience with viral vector upstream processes, particularly experimentation in and operation of stirred-tank bioreactors
- Working knowledge of GMP guidelines for clinical manufacturing
- Strong scientific reasoning, problem-solving, and applied mathematics and statistics skills, including the ability to break down complex problems into manageable hypotheses
- Proficiency in using Microsoft Word, Excel, Power Point and data analysis/presentation software such as JMP and/or GraphPad
- Excellent interpersonal, verbal and written communication skills
- Strong organizational & problem-solving skills, with excellent attention-to-detail and the proven ability to collaborate in a dynamic team environment
Preferred experience & skills:- Experience implementing processes in clinical and commercial manufacturing of cell and gene therapy products
- Demonstrated ability to apply knowledge of cell biology, chemical engineering, or bioengineering toward process development, scale-up /scale-down and troubleshooting
- Detailed understanding of bioreactor operation and control loops
- Experience drafting CMC sections for INDs
- Proven experience collaborating with internal and external partners
Our values: Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.
Determined to deliver: By working with focus and passion, we can provide patients with the solutions they need.
Own every outcome: We can reach new heights when we stay centered on our shared success.
Collaboration at the core: When we band together, our work is better.
Feedback is fundamental: Constructive and authentic positive feedback may be difficult to master but it is vital to our success.
Working here:- We offer a highly competitive compensation package with meaningful ownership through equity
- Excellent coverage for medical, vision, and dental
- 401(k) with generous contribution
- Life insurance
- Flexible PTO policy
- Additional substantial benefits
