Based with a young Dublin pharma start-up, the newly created role of Technology Transfer Technical Expert, Global Manufacturing & Supply Chain, is primarily responsible for managing the technology transfer, manufacture and supply chain for a commercial injectable product, and supporting similar activities for other late stage projects in the pipeline. This position will also serve as the primary point of contact for commercial supply to regional partners and support supply chain and sourcing efforts in Europe and ex-US regions.
While this role can be set at either Associate Director, or Director level our client is looking for someone who will be hands-on in the details of technology transfer including reviewing developmental and production data, and overseeing manufacture.
This important, high profile position is an individual role with no direct reports, and will report to functional management based in the US, with dotted line responsibility to the site head in Ireland. This role involves working very closely with the US Technical Operations and Quality teams in an integrated environment.
This role is also responsible for managing the supply of appropriately labelled clinical trial materials for study sites in Europe. Other potential responsibilities include cross-functional technical audits and vendor management of contract manufacturers in Europe, and logistics management of GMP drug substance and drug product.
Duties and Responsibilities
- Managing the technology transfer manufacture, and packaging of a sterile injectable commercial product, to a new contract manufacturer in Asia.
- Working with the Quality team to release the commercial product for global markets.
- Working with Commercial operations and Sales team to support product forecast and plans for manufacturing.
- Working with regional commercial partners to supply commercial product and support regulatory filings.
- Working with the EU Quality representative to release and manage supply of clinical trial materials in Europe
- Working with US supply chain group to coordinate and to manage distribution of CTM to depots and sites for clinical studies in Europe.
- Participate in GMP audits of European contract manufacturers as a technical representative, as needed
? Masters/PhD degree in chemistry, pharmacy or related fields
? With a career that includes small molecule manufacture or development experience, the preferred candidate must have extensive experience in sterile injectable drug product technology transfer and
? At least 10 years industry experience in CMC with focus on late stage (Phase 3) and Commercial product.
? In-depth understanding of CMC, GMP quality, and clinical operations.
? Experience with managing contract manufacturing and research organizations
? Working knowledge of import and export requirements in a regulated environment, particularly for EU countries.
- Ability to work effectively and independently, with functional counterparts primarily located in USA
- Team player with demonstrated strong interpersonal skills, clear oral and written communication skills
- Exceptional attention to detail, strong computer and organizational skills
- Travel requirements up to 25%
Cv to Gerry@rftgroup.ie