Associate Director of Process Development
12 hours ago
Vor Bio is seeking an Associate Director/ Director of Process Development to join our Process and Analytical Development group. As a key member of our team, you will oversee the design, development, and characterization of gene edited hematopoietic stem cells (eHSC) and CAR-T manufacturing processes to support early and late phase clinical trials.
Key Responsibilities:- Optimize cell therapy manufacturing process, execute process characterization, author process control strategy, and support process validation
- Develop, characterize, and validate critical starting material manufacturing processes, e.g., Cas9, gRNA, and lentiviral vector production
- Establish strong collaborative relationships and represent Process Development function across the organization and with external partners
- Author and review technical reports, regulatory documents, and patents as necessary
- Champion a protocol-driven and report results methodology
- Maintain and foster a positive, supportive, and collaborative team culture
- PhD in the pertinent life sciences or engineering, with 10+ years relevant experience
- Excellent cross-functional communication skills
- Expertise (5-7+ years) leading process development of HSC and/or CAR-T products
- Process development experience in late-stage program is highly desired
- Understanding of cGMPs and demonstrated experience leading groups with substantial contributions to regulatory filings
- Understanding of manufacturing processes for genome editing reagents including Cas9, gRNA, lentiviral vectors
- Demonstrated track record of consistently meeting deadlines in a dynamic, fast-paced environment
- Experience in process characterization and validation is a plus
- Competitive health, dental, and vision coverage
- Life insurance, and short term and long-term disability insurance
- Discretionary time off, parental leave, and an excellent 401(k) package
- Generous transportation stipend to commute as you wish
We are an equal opportunity employer and invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Please visit our website at https://www.vorbio.com/ for more information.
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