AX-7256 Technical Director, External Manufacturing
This Global specialty-driven biotech company requires a candidate with experience in development, manufacture and testing of Drug Substance and/or Drug Products for this broad ranging leadership role.
- Global specialty-driven biotechnology group
- Offer products in oncology and endocrinology amongst others
- Strong pipeline
- Launches anticipated over the next 2 years
- The purpose of the role is to lead the External Manufacturing Organisation technical team, taking accountability for providing technical support and expert advice to Regulatory CMC and Quality teams on all Drug Substance and Drug Product manufacturing and testing activities performed at CMOs, Contract Testing Laboratories (CTLs) and partners.
- Accountable for analytical batch release testing and stability testing performed under contact with CMO’s and CTL’s. The activities include technology transfers, development and/or remediation of analytical methods, compiling CofA’s and trending/release of stability data. Ensuring that all changes to process are risk assessed to provide assurance of the best possible outcome for the end to end supply chain of EMO products.
QUALIFICATIONS / EXPERIENCE REQUIRED
- As a minimum: Degree in a technical discipline related to life sciences (e.g. biochemistry, chemistry, (bio)chemical engineering, pharmaceutical technologies)
- Significant, hands on experience in development, manufacture and testing of Drug Substance and/or Drug Product.
- Management of teams at Manager Level including a solid experience in technology transfer of manufacturing processes.
- Experience with Biopharmaceutical products, Dual Drug Substance and Drug Product development or manufacturing experience preferred.
- Ideally solid experience in technology transfer of manufacturing processes.
For a confidential discussion please telephone Rebecca Bray at AXESS Limited on 020 8560 2300 quoting reference 7256.
To apply, please click the APPLY ONLINE button.
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