We are looking for an experiencedSenior Scientist for a fantastic 2.5 year contract remote based.

You will be working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.



Primary Purpose / Regulatory Responsibilities:

• 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.
• Represent the DP development project team on the TST.
• 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.

Experience:

• Minimum 3 years experience in sterlie drug product development and/or manufacturing within the pharmaceutical industry is required. Experience within the biopharmaceutical
• industry is an advantage
• 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 optimisation. Good knowledge of cGMP.
• An understanding of the issues and challenges of product development at phase 1 is an advantage