Job Reference: J5635437
Updated On: 08/09/2021
Status: Now Interviewing
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Role OverviewWe are currently looking for a Bioassay Lead Scientist to join a leading Biopharmaceutical company based in the North West of the UK, commutable from Cheshire and Liverpool. As the Bioassay Lead Scientist you will be responsible for the development of Bioassays for the analytical assessment of novel Biotherapeutics.
This is a senior opportunity where you will lead on projects and take ownership of vital work flows for developing products.
Key Duties and ResponsibilitiesYour duties as the Bioassay Lead Scientist will be varied however the key duties and responsibilities are as follows:
1. Develop and run Bioassays to reflect product mode-of-action to support batch release, stability and product characterisation for new drug candidates through to pre-clinical and clinical phase molecules.
2. Proactive scientific and technical input to the design, development and validation of effective fit-for-purpose and robust bioassays including in vitro cell-based assays, binding and immunoassays and BoNT protease activity assays.
3. Participate in the design, execution and reporting of bioassay qualification and validation protocols as well as adhere to cGMP regulations and ensure QMS are updated and followed.
4. Support Regulatory documentation writing for IND/IMPD submissions, as required.
Role RequirementsTo be successful in your application to this exciting opportunity as the Bioassay Lead Scientist we are looking to identify the following on your profile and past history:
1. Relevant PhD or lower degree within the field of Cell Biology, Biochemistry or Pharmacology where you also have experience of working in the Pharma / Biopharma industry and demonstrate a subject matter level expertise in Bioassay development.
2. Proven industry experience where you have lead and managed the scientific direction of work projects and have lead the development of Bioassays in an industrial setting.
3. A working knowledge and practical experience with the following techniques: Mammalian Cell Culture, Potency Assays, Reporter Gene Assays, Florescence assays, Proliferation assays and Immunoassays.
Key Words: Bioassay | Cell-based Assay | In Vitro Assay | Assay Development | Analytical Development | Protein Characterisation | Product Charaterisation | Potency Assay | Proliferation Assay | Reporter Gene Assay | cGMP | GMP | Biopharmaceutical | Biologic | Biotherapeutic | SME | Subject Matter Expert | CMC
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