Life Edit is looking for an experienced CMC professional with strong organizational, strategic, and communication skills, and the desire to be part of a highly collaborative and cross-functional team. The successful applicant will define and execute on CMC strategy for Life Edit’s clinical programs. . A strong background in CMC and process development, and experience with mRNA and/or protein manufacturing will be critical for success in this role. This is an exciting opportunity to help build a successful therapeutics company from an early stage.
Here’s What You’ll Do:
- Develop and direct the CMC strategy to support Life Edit’s clinical development programs
- Establish goals and ensure operational execution of CMC development plan
- Oversee external process and analytical development to support the manufacturing of proteins, mRNA and synthetic guide RNA for cell therapies
- Collaborate effectively and leverage internal R&D, technical operations and quality teams as needed to achieve goals
- Serve as a contact for interactions with regulatory agencies including preparation of relevant portions of IND filings (i.e. Module 3) and other regulatory communications
- Maintain knowledge of regulatory guidance on cell and gene therapy CMC.
- Advanced degree (M.S. or Ph.D.) in biology, biochemistry, chemistry, chemical, biochemical, or biological engineering.
- Experience entering biologic drugs into the clinic, IND (or equivalent) submissions, and preferably BLA (or equivalent) submissions.
- Leadership experience in process and analytical development, working with CDMOs and CROs to support scale up and manufacturing.
- Experience with ex vivo gene editing, and cell/gene therapies is highly preferred.
- Substantial experience with the oversight of process development of the production and manufacture of proteins and/or nucleic acids.
- Understanding of drug development and regulation and familiarity with current regulatory guidance related to cell and gene therapies.
Why join Life Edit Therapeutics?
Life Edit Therapeutics, an ElevateBio portfolio company, is a gene editing company on a mission to rewrite the future by curing disease, making any edit, anywhere. Life Edit has built a world-class genome editing platform with one of the world’s largest and most diverse collections of novel RNA-guided nucleases (RGNs) and base editors. The company’s next-generation editing systems will propel the development of novel human therapeutics by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies.
Our Vision: To pave the way to faster, safer, gene editing therapeutics that cure disease and improve patient lives
Life Edit is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Life Edit will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.