About Ancilia

Ancilia Biosciences is a venture-backed startup leveraging CRISPR’s natural function in bacteria to develop a new class of live biotherapeutics for a range of applications. Our work is interdisciplinary and lies at the intersection of the microbiome, the virome & CRISPR.

Fermentation Scientist

As a Fermentation Scientist, your primary goal will be to develop fermentation and downstream processes for the manufacturing of Ancilia’s live biotherapeutic products (LBPs). You will help stand up the company’s process development and small-scale GMP manufacturing capability (including laboratory equipment, protocols, and establishment of best practices). You will develop bioprocesses for manufacturing strains comprising the drug substances (DS) for Ancilia’s programs and support the development of drug products (DP). You will work closely with Analytical and Quality efforts to develop and validate release assays and provide inputs into regulatory submissions. This role will benefit from experience in traditional cGMP manufacturing of LBPs as well as willingness to experiment and innovate on CMC pipelines for LBP manufacturing.

Responsibilities

● Lead the development and execution of bioprocesses for small-scale DS manufacturing. Bioprocesses shall include microbial fermentation, cell harvesting, cryogenic and lyophilization preservation, and cell bank generation.

● Coordinate with Assay Development to develop in-process testing and end-of-process release testing

● Assess equipment needs for fermentation processes and cGMP operations

● Perform GMP manufacturing of DS and DP in-house in support of clinical programs

● Author, review, and approve Development Reports to support cGMP documentation and regulatory filings

● Support development of cGMP SOPs, MBRs, and Specifications

● Assist in cGMP Quality operations including tech transfer and product disposition

● Work with regulatory colleagues to prepare FDA-facing materials for pre-IND meetings and IND filings

● Serve as the technical lead overseeing bioprocess activities at CDMOs

● Train research associates assisting with bioprocess development and CMC operations

Required Qualifications

● Masters with 3+ years of industry experience in microbiology, fermentation, or related field (or Bachelor's degree with 5+ years of experience)

● Proficiency in microbial fermentation and long-term cell preservation

● Experience operating bioreactors or fermentors and developing processes to maximize biomass and viability

● Experience operating cell harvesting equipment and developing cell harvesting processes that maintain cell viability

● Proactive, driven, and creative work style spanning experimental design to data analysis, with an emphasis on successful problem-solving to advance programs

● Strong written and verbal communication skills, including ability to communicate technical material to expert and non-expert audiences simply and clearly

● Ability to achieve key milestones under defined timelines

● Ability and desire to learn quickly and grow in a fast-paced, collaborative environment

Preferred Qualifications

● At least 2 years of experience in pharmaceutical/biotech CMC for manufacturing LBPs

● Experience interacting with regulatory consultants and the FDA through briefing packages and filings

● Familiarity with the practical application of Current Good Manufacturing Practices (cGMPs) to drug development and manufacturing for early-stage clinical trials

-This position is full time, on location in New York City. Compensation in the range of $120k -$160k/year commensurate with experience