MS or Ph.D. in Chemical Engineering, Bioengineering or related discipline
Minimum of 10 years in downstream purification process development within biopharma
Proven team management experience
Technical expertise in clarification, TFF, chromatography, and sterile filtration
Experience with both scale up and scale down processes
Knowledge of cGMP and regulatory biopharmaceutical requirements
Strong organizational, problem-solving, and communication skills
Responsibilities
Oversee planning and execution of tech transfers for viral products at CDMOs
Act as the downstream subject matter expert for internal and external teams
Build internal downstream capabilities and procure scale down models
Design and conduct studies to optimize critical process parameters across purification steps
Maintain detailed lab notebooks and ensure accurate data analysis
Author and review key technical documents and regulatory submissions
Represent the company at professional and regulatory meetings
Collaborate across functions to advance clinical programs
Benefits
Competitive compensation package with equity ownership
Comprehensive medical, vision, and dental coverage
Generous 401(k) contributions
Life insurance coverage
Flexible PTO policy
Additional substantial benefits
Full Job Description
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:
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
