- Establishment of robust, fit for purpose biologicals drug product manufacturing processes for the different development phases (FIM, Ph2, Ph3).
- Defining and selecting drug product manufacturing processes and parameters for clinical manufacture.
- Build close collaboration with the External DP Clinical Manufacturing Team for the establishment of drug product processes and manufacturing of stability and clinical DP batches.
- Support the development and implementation of the DP CMC development strategy within BCPDS.
- Support the definition of DP processes for different types of formulation (liquid in vials, PFS or other container, solid (either lyophilized or spray dried), and any other more innovating formulation addressing parenteral route of administration or other requirements for clinical development and future commercial manufacture.
- Provide all appropriate support to drug product process development activities (eg filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc) as required for clinical development.
- Provide support to ensure timely delivery of stability and clinical DP batches.
- Provide support to ensure the validation of commercial DP processes for late-stage projects.
- Ensure capturing critical process data and allow appropriate analysis of processes.
- Ensure appropriate batch record review to ensure capturing critical process data and allow appropriate analysis of processes.
- Provide support in the completion of the relevant sections of the Product Specification File and CMC regulatory submissions and regulatory briefing documents and ensure appropriate response to questions from authorities.
- Minimum 3 years experience in sterile drug product development and/or manufacturing within the pharmaceutical industry is required.
- Experience within the biopharmaceutical industry is an advantage with good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) would be required.
- Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization. Good knowledge of cGMP.
- An understanding of the issues and challenges of product development at phase 1 is an advantage.
- Knowledge in primary packaging and regulatory requirement is an advantage.
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Senior Scientist - Slough, Berkshire, United Kingdom - SRG
Description
Job Title: Senior Scientist – Global Biopharmaceutical
Contract: 2.5 year contract
Location: Slough
Salary: £ £23.95
SRG are working with a Global Biopharmaceutical company to help them find a Senior Scientist to join their busy team. This is an exciting opportunity for an individual experienced in drug development.
Key Responsibilities will include:
Candidate Requirements:
