About Prevail Therapeutics
Prevail is a New York City-based biotechnology company focused on developing novel gene therapies for Parkinson’s disease and other genetically-defined neurodegenerative diseases. Prevail is based in the Alexandria Center for Life Science.
The Director of Process Development will report to the Chief Technology Officer and will play a critical role in our efforts to advance the development of AAV gene therapy pipeline drugs for neurodegenerative disorders. We are looking for an enthusiastic, self-motivated, technical leader with excellent interpersonal skills who is comfortable working in an open environment spanning multiple functions.
As an early hire at a new company, you will have exposure to senior management, to all activities at Prevail, and you will be influential in championing and developing our culture. Our employees are expected to function with a high degree of independence in a fast-paced startup company, while working collaboratively within a multidisciplinary team that is dedicated to the development of new therapies for neurodegenerative diseases.
- Lead build-up an internal process development lab to design and perform upstream and downstream process development studies for AAV gene therapy drug substances
- Build up and manage the process development group including recruitment of new hires, training and mentoring staff, managing performance and development of staff, operations of the group
- Ensure and maintain a proper scientific rigor within the group, and contribute to developing process development and manufacturing related budget
- Lead technical interactions with CDMOs and CROs for process development and technical supports for external GMP Manufacturing
- Assist leading the CDMO management to develop, build, and maintain strong productive relationships
- Participant in internal and external analytical development for the in-process and product assays
- Author and review relevant regulatory filing sections related to process development and CMC
- Establish and maintain a robust communication to all relevant internal function groups within company and external partners, build and maintain a network consisting of industrial experts
- Develop and implement project execution plans to achieve short-term and long-term goals while ensuring alignment of regulatory requirements
- Relevant Ph.D. in a scientific discipline with a minimum of 8 years (or a MS with a minimum of 10 years) of industry experience required. Title and compensation will be commensurate with education and experience
- Experience in hands-on AAV gene therapy process development required
- Experience in external CDMO/CRO management required
- Demonstrated leadership and proven experience on management of a professional function group
- Experience with policies, guidance, process and procedure of regulatory agencies and with quality assurance and quality control systems
- Creative thinking, high level of ownership, multitasking in a fast-paced work environment
- Strong interpersonal and organizational communication skills, and a team player
We offer competitive compensation and benefits, including paid time off, health insurance, life insurance and flexible spending accounts. Prevail is an Equal Opportunity Employer.
Please apply by sending your CV to firstname.lastname@example.org.