Advanced Biopharmaceutical Process Developer
1 month ago
At Lifelancer, we are seeking an experienced Senior Scientist to join our team in a remote-based contract role. This is a fantastic opportunity for professionals looking to advance their careers in the field of biopharmaceutical process development.
About the RoleThis 2.5-year contract position involves working with a global biopharmaceutical organization committed to improving the lives of people affected by neurological and immunological diseases.
Key Responsibilities- Establish robust drug product manufacturing processes for various development phases (FIM, Ph2, Ph3).
- Define and select drug product manufacturing processes and parameters for clinical manufacture.
- Collaborate closely with the External DP Clinical Manufacturing Team to establish drug product processes and manufacture 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 formulations (liquid in vials, PFS or other containers, solid (lyophilized or spray dried), and innovative formulations addressing parenteral routes of administration or other requirements for clinical development and future commercial manufacture.
To be successful in this role, you will require:
- A minimum of 3 years' experience in sterile drug product development and/or manufacturing within the pharmaceutical industry.
- Experience in the biopharmaceutical industry is advantageous.
- 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).
- 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 beneficial.
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