HEAD OF PROCESS aNd ANALYTICAL DEVELOPMENT/CLINICAL MANUFACTURE
Vedanta is pioneering the development of a new class of therapies that act by modulating the composition of the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune, infectious, and metabolic diseases in ways that are completely different from existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Ventures and a team of world renowned experts in immunology and microbiology.
Position Description / Responsibilities
Vedanta is looking for a talented Head of Process and Analytical Development (P&AD) who will also be responsible for in-house Clinical Manufacture. The candidate will lead a P&AD team tasked with translating scientific results from the discovery team into scalable, reproducible, and robust production processes and Quality Control assays that yield a product of constant quality. The candidate will also manage technology transfer to Contract Manufacturing Organization partners for future commercialization.
The candidate will:
- Oversee the Process and Analytical Development efforts at Vedanta to help characterize the parameters that define the drug products to be produced, and ultimately produce clinical supplies.
- Help recruit, manage, and mentor a team of process and analytical development engineers and research associates.
- Work with Vedanta's Quality Assurance officer to set up a QA system that can be used to generate and release clinical material.
- Work closely with the discovery team to enable a seamless technology transfer to P&AD, including advising on properties affecting candidate selection, setting up assays in the research phase that serve as release assays in later development, or standardization of bacterial growth conditions.
- Be responsible for preparing the CMC sections of IND applications.
- Liaise with suppliers of process development and analytical equipment.
The job title and level will be corresponding to work experience, education level, and skills of the selected candidate.
- 10+ years of relevant experience in Process and Analytical Development in the biotech or pharma industry, preferably having worked for or managed Contract Manufacturing Organizations.
- PhD and research experience in microbiology and bioprocess engineering
- Track record of developing scalable production processes and accompanying analytical methods, preferably including experience with live biotherapeutics or live vaccines.
- Tangible experience in fermentation of anaerobes and primary processing.
- Track record of team leadership and mentoring reports.
- Entrepreneurial and self-motivated work style.
Please send your resume and cover letter to email@example.com
All other questions or inquiries should also be directed to the same email address.