This is a great opportunity for a Technical Manager to join a well-established organisation based in Berkshire.
The (Senior) Technical Manager is accountable for the technical supervision of all Drug Substance and Drug Product manufacturing and testing activities performed at Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs), including the development of all technical documents required for the Technology Transfer of these activities to alternative sites/CMOs/CTLs.
The will assume primary responsibility for providing technical leadership and support on product manufacturing and testing to Third-Parties and to the Quality and Regulatory CMC functions within the Company’s External Manufacturing Organisation. In the context of Technology Transfers, he/she will oversee authoring and/or reviewing all relevant supporting technical documentation (e.g. plans, protocols, reports) and CMC sections of Regulatory dossiers.
Main job responsibilities:
- Act as the Technical Leader within the External Manufacturing Organisation.
- Coordinate and supervise the work of all technical contributors within the External Manufacturing Organisation.
- Build a competent and agile Technical function in support of the Company’s varied portfolio of externally manufactured products.
- Build strong relationships with the company’s global internal network of technical experts, leveraging support from other Technical Operations teams as and when required.
- Establish a strong technical credibility with partners, CMOs and CTLs, and provide support to Third-Party Subject Matter Experts (SMEs) in technical problem resolution.
- Technology Transfers
- Act as the External Manufacturing team’s primary point of contact with SMEs at CMOs/CTLs.
- Author and/or review key master documents (plans, protocols, reports) to support Technology Transfer activities involving CMOs.
- Review and comment on technical documentation authored by SMEs at CMOs/CTLs.
- Assist in the resolution of manufacturing and testing issues at CMOs/CTLs and provide strong problem solving support to partner SMEs
- Provide technical writing support for Regulatory CMC activities
- Act as a member of the External Manufacturing team’s Change Control Committee.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Nixon on +44(0)203 0789 544 or upload your CV on our website www.proclinical.jobs . Full job description available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.