Job Reference: J5634742
Updated On: 07/04/2021
Status: Open to Applications
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Role OverviewHyper Recruitment Solutions are currently looking for a Technical Transfer Scientist to join a leading Pharmaceutical Company in the Essex Area, To manage and provide technical/analytical support associated with the ongoing manufacture of new/existing products as well as the Technical Transfer of Drug Product to alternative CMO's.
Key Duties and ResponsibilitiesYour duties as the Technical Transfer Scientist will be varied however the key duties and responsibilities are as follows:
You will develop project plans (product site transfers or new product development projects), to include time-scales, costs and identifiable risks, and take ownership that issues recognised within the project are resolved, time-lines are met and where necessary, appropriate data generated.
1. The Technical Transfer Scientist you will manage and implement agreed project plans in accordance with the product licences and GMP Guidelines and be responsible for creating and approval of Quality and Technical Agreements between the organisation and its partner Contract Manufacturing Organisation. This will include the Generation, review and technical approval of Technical documentation including but not restricted to Protocols, Manufacturing and Packaging Batch Manufacturing Records, Validation Reports, Specifications, Tooling Drawings.
2. Ensure compliance in Technology Transfer and Process Changes with EU GMP and resolve Technical and Quality issues including unforeseen deviations relating to the production and testing of products by Contract Manufacturers and Testing Laboratories. You will report issues to the QP who is responsible for releasing these products to the market.
3. Assist in sourcing alternative API suppliers, Drug Product, Primary and Secondary manufacturers.
Role RequirementsTo be successful in your application to this exciting opportunity as the Technical Transfer Scientist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science or Related Discipline
2. Proven industry experience in Oral Solid Dose Formulation/Technical Operations
3. A working knowledge and practical experience with Oral Solid Dosage Forms.
Key Words: Pharmaceutical, Chemistry, Technology Transfer, Scale-up, Manufacturing, Solid Dose, Oral Suspension, ICH Q8, GMP, CMO, CDMO, MS&T, Manufacturing Science and Technology, Analytical, New Product Development (NPD), New Product Introduction (NPI), Tablets, Capsules.
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