Product Development Director
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Hobson Prior are currently looking for a Product Development Director - Peptides to join a top T cell vaccine organisation in the North Wales with the flexibility to be remote based with 1-2 days a week on site. This is an excellent opportunity for a Product Development Manager / Formulation Manager who has experience leading the development of peptide-based products.
Please note that to be considered for this role you must have the right to work in this location.
- Responsible to manage CDMOs and CROs to develop formulations and processes, tech transfer to commercial manufacturing site, fill and finish, and set-up stability studies for the company's peptide containing products.
- As the Subject Matter Expert, you will work extensively with Reg Affairs to support preparation of IMPD, IND, BLA, MAA and participate in Scientific Advice meetings with regulatory authorities.
- You will review experimental plans/ validation protocols/ results/ technical agreements/ master BMRs/ reports written by vendors and ensure these meet requirements.
- To provide support to QA activities, including but not limited to deviations, out of specifications, CAPAS etc. that arise at CDMOs, CROs and internally.
- Excellent time management skills.
- Ability to plan activities and co-ordinate across multiple vendors.
- Relevant degree in a Life Sciences subject, including but not limited to Biological Sciences, Biochemistry. A PhD is advantageous.
- Proven track record in the biopharmaceutical industry, with significant experience with the formulation development and process development of peptide-based products.
- Knowledgeable and with significant experience with drug product manufacturing in GMP regulated environments for clinical trial supplies and tech transfer manufacturing sites.
- Experienced in preparation of drug product sections of IMPD/ IND/ MAA/ BLA.
- Prior experience of managing CDMOs/ CROs in an out-sourcing environment.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.