Senior Scientific Officer – GMP Biologics Manufacturing
Our Client is a major force in the research and development of biotherapeutics for the treatment of cancer. They now require an experienced downstream processing scientist to join their team
The role is to lead on the process development, scale-up and GMP manufacture of novel biologics investigational medicinal products for early phase clinical trials. The role provides technical and scientific expertise on a broad range of biologics product types and design robust manufacturing processes.
The role is in a matrix management environment utilising cross-functional skills in protein / antibody purification development and manufacture and cell culture / fermentation technology. A good understanding of protein / antibody characterisation methods is desirable for this role.
• Perform and supervise downstream processing in a Process Development and GMP environment
• Take the technical lead on development, scale up (200L +) and GMP manufacture of downstream processing of monoclonal antibodies, recombinant proteins, DNA or viral vectors
• Assist in the day to day maintenance, operation and validation of the production facility and production equipment
• Work closely with the Project Leads, Production, and Quality Control to generate realistic project schedules
• Develop and generate appropriate process descriptions to support the generation of product specification files and batch manufacturing records
Key Behaviours and Competencies:
• Demonstrate expertise in downstream processing and the procedures required to develop novel biologics products for Phase I clinical trials
• Demonstrate a good understanding of GMP and its application to the manufacture of sterile biologics products
• Have experience in sterile processing and its qualification
• Knowledge and experience of one or more of these product types: monoclonal antibodies, recombinant proteins, DNA, viral vectors or cell therapy products
• An effective communicator. Able to build a good working relationship with a wide range of other groups.
• Attention to detail and excellent record keeping skills
Key Technical Skills, Knowledge and Experience:
• Science degree level or above, with a minimum of five years of experience in a GMP biotechnology/ pharma field with particular focus on downstream processing
• Experience of the downstream development / scale up and manufacture of biologics
• Good technical writing ability to generate process development / manufacturing reports and of writing clear and unambiguous manufacturing instructions (BMR’s /WI’s and SOP’s)
• Ideally, experience of working with mammalian and bacterial cell culture using stirred tank disposable bioreactor technology, with an understanding and experience of qualification of sterile manufacturing processes through process simulation tests
Salary: Negotiable + Benefits
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