(Associate) Scientist, Upstream Viral Process Development

• 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

We are an equal opportunity employer.

We do not discriminate on the basis of race, religion, gender, sexual orientation, age, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.