Manufacturing Development Manager, London based. Our client is an innovative biotechnology company that applies synthetic biology to the development of novel oral vaccines and cancer immunotherapies. We are looking for a highly motivated, detail-oriented person experienced in chemistry, manufacturing and controls (CMC) of live microbial products, including direct management of manufacturing activities. The successful candidate will oversee the project management, scale-up and outsourced manufacture of a two strain Salmonella-based vaccine candidate already in Phase 1, as well as work within the lab for characterization of preclinical strains for immunotherapy and drug product formulation for later clinical development.
You will work within the Clinical Development team that is mainly supported by external experts and consultants. You will be responsible, with support of a highly experienced external consultant, for selection of an appropriate contract manufacturing organisation (CMO) and oversee the tech transfer, process development and scale-up of the whole manufacturing process. Additionally, you will work alongside the R&D team in the lab, supporting strain characterisation for our client’s new immunotherapy program that is expected to enter the clinic in 2020. You will be expected to be a self-starter and will be prepared to be hands on. You will be collaborating with all members of the clinical and non-clinical teams daily.
Candidates to have:
- PhD in biochemistry, microbiology or biochemical engineering
- Demonstrated 5-10 years’ experience or more at an appropriate level in microbial process development and drug substance scale-up
- Familiarity with drug substance and drug product manufacture including fermentation and lyophilization of bacterial products
- Demonstrated project management experience at high-level
- Experienced in building relationships with and overseeing CMOs
- Experienced in developing productive and cGMP compliant manufacturing processes
- Ability to work independently with little need for oversight