Associate/Director, Process Development
The complex ecosystem of bacteria that comprise our gut microbiome are inextricably tied to the overall quality of human health. Federation Bio is a new start-up company poised to leverage the power of active microbial communities to address high unmet medical needs. Our approach lies at the intersection of microbiology, chemistry, and genomics and uniquely enables us to harness the power of the microbiome and define the potential of this new therapeutic modality.
Federation was founded by two leading academics in the microbiome field (Stanford Professors Michael Fischbach and Dylan Dodd) as well as Venrock, one of the leading venture capital funds in the United States.
Description of Role
We are currently seeking an experienced, creative, and highly motivated Process Developer to build in-house manufacturing capabilities including but not limited to: innovative systems, building a team, and identifying and removing barriers to efficient production of complex communities of anaerobic microbes. This person would be responsible for the overall bioprocess development and implementation strategy in collaboration with the research team including a role in influencing research direction and strategies for strain selection. Additional responsibilities include hands on process development around the early research grade and GMP material at Federation Bio. A core focus is the ability to rapidly develop processes to culture, purify, and combine diverse anaerobic bacteria for therapeutic use. This process developer will play a critical role in the development of novel microbiome therapeutics to support the development of exciting new therapies across a variety of diseases.
Core responsibilities and opportunities are:
- Design and development of internal scalable fermentation processes for a variety of anaerobic microbial strains
- Manufacturing master cell banks, combined communities, and final drug product in an early phase GMP environment
- Setting appropriate release specifications for the components of the drug substance as well as the final drug product
- Identifying and qualifying analytical methods in order to ensure the delivery of quality products for dosing
- Authoring CMC sections of briefing books and/or other submissions (e.g. IND) for regulatory authorities
- Preparing media, buffers, single-use components for GMP use
- Operating and maintaining small-scale process equipment
- Ordering and inventorying raw materials
- Coordinating 3rd party contractors and vendors as needed
- Collaborate with experimental biologists to design well-controlled experiments, develop best practices for strain growth and characterization
- Communicate clearly, work independently, collaborate heavily, think critically
- Extensive experience with bioprocess development of anaerobic microbes or other types of cultures
- Experience in media optimization and developing scalable downstream production processes
- Authorship of early phase CMC regulatory submissions for products containing live bacterial products (LBP)
- Familiarity with LBP FDA regulations and GMP standards
- Advanced and applied mathematics for process modeling, network analysis, metabolomics
- Proven track record for rapid development, IP innovation, and scale-up for early-phase biologics
- BS preferably in chemical or bioengineering, mechanical engineering, or related technical discipline
- At least 7 years of hands-on experience in early process development
- Direct experience with cell banking, cell culture, fermentation, lyophilization, and/or capsule filling is desired.
Our ideal teammate is creative, flexible, rigorous, and innovative, with a well-developed ability to operate effectively within a multidisciplinary team in a fast-paced environment.
Competitive salary and benefits