Principal Scientist, Viral Downstream Process Development

About the role

The Principal Scientist will serve as the downstream processing expert working closely with CDMOs to generate lentivirus and adenovirus products. Reporting into the Senior Director of Process Development, this individual will also be responsible for building out the internal downstream purification capabilities within process development to support scale up and scale down.

Key responsibilities

• Oversee planning and execution of tech transfers, development and scale up of viral products being manufactured at CDMOs
• Serve as the downstream subject matter expert on both internal and external (CDMO, equipment suppliers, etc.) teams
• Build out internal downstream capabilities by identifying/procuring scale down models for process development
• Design and execute studies to identify critical process parameters and optimize process setpoints across the clarification, Tangential Flow Filtration (TFF), chromatography and sterile filtration steps
• Responsibility for execution, data review, analysis, and maintaining accurate and detailed lab notebooks
• Author and review technical documents, including but not limited batch records, SOPs and development reports and process-specific sections of regulatory documents
• Represent the company externally at meetings (professional associations, with regulatory bodies, etc.)
• Work cross-functionally with analytical development, research and development, program management to advance clinical programs

Required experience & skills

• MS or Ph.D. in Chemical Engineering, Bioengineering or related discipline
• Minimum of 10 years of experience with downstream purification process development in the biopharma industry
• Experience directly managing a team
• Technical experience with downstream unit operations including clarification, TFF, chromatography, sterile filtration and formulation
• Experience with scale up and scale down of purification processes
• An understanding of cGMP and regulatory requirements for biopharmaceuticals
• Strong organizational & problem-solving skills, with the proven ability to collaborate in a dynamic team environment
• Strong scientific reasoning, problem-solving, and applied 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
• Excellent organizational and planning skills, strong work ethic and the desire to work in a flexible and fast-paced, entrepreneurial environment

Preferred experience & skills

• Experience with Quality by Design (QbD) approach to drug development including risk assessments, Design of Experiments (DoE) and statistical methods
• Experience drafting CMC sections for INDs
• Experience with technology transfers to external manufacturing facilities

Our values

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, and 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.