Job Reference: J5631335
Updated On: 03/05/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior API Development Manager to join a leading Drug Development company based in the Oxfordshire area. As the Senior API Development Manager you will be responsible for coordinating API development activities ensuring the needs of both clients and internal collaborators are met.
Key Duties and ResponsibilitiesYour duties as the Senior API Development Manager will be varied however the key duties and responsibilities are as follows:
1. You will work with the Director of Chemistry to understand key project goals and subsequently ensure projects are performed to a satisfactory standard and delivered to budget and schedule, this will be achieved through guidance, supervision and training being provided to Scientific/Technical Staff.
2. The Senior API Development Manager will communicate regularly with both clients and internal departments to ensure that projects meet defined expectations. You will be expected to write proposals and develop business relationships with potential clients.
3. You will manage project meeting, telecommunications, and effectively communicate progress of projects to internal and external bodies, as well as manage materials and resources required to ensure that the projects needs are met.
4. Ensure that all technical documentation (laboratory production, cGMP production, pilot plant projects, analytical methods) and Health and Safety documentation is maintained and complies with relevant regulatory/quality guidelines with the aim of ensuring that Quality Standards are upheld.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior API Development Manager we are looking to identify the following on your profile and past history:
1. Relevant degree/PhD in a Chemistry/related discipline.
2. Proven industry experience in project/line management in the Pharmaceutical Industry primarily in a CRO/cGMP compliant environment
3. A working knowledge and practical experience with the development/scale up of API's during the clinical trial manufacture phase.
Key Words: API / Development / GMP / GxP / Chemistry / Organic Chemistry / Process Chemistry / Project Management / CRO / Drug Discovery / PRINCE2 / Clients / Organic / Synthesis / Synthetic / cGMP / HPLC / LC-MS / NMR /
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