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  • Job reference: RMS0165712

Senior Scientist - MCC Upstream Process Dev Lead

  • Sector: Engineering
  • Location: Billingham
  • Job type: Permanent
  • Date posted: 02/08/2016
  • Time left:
    d h m s
This vacancy has now expired.
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The Company:
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .

The Role:
An accomplished technical leader who can demonstrate a strong track record for the successful development, optimisation, characterisation and transfer to cGMP manufacturing of state-of-the-art mammalian upstream manufacturing processes – applies extensive scientific and technical experience and business acumen to drive high-quality laboratory work, and deliver well-controlled and characterised upstream manufacturing processes to aggressive timelines. Projects will range from early phase to commercial stage biologics.

Provide leadership and direction to the process development sub-group within Mammalian Cell Culture R&D, a group of 3-15 scientists.

Technical Skills Requirements

• Design, develop and scale up reproducible and robust cGMP compliant mammalian cell culture upstream processes.

• Provide strong scientific and technical leadership in the application of Design of Experiments (DoE) and appropriate cell culture scale down models.

o Experience in: media / feed screening, development, and optimisation; feed strategy; process parameter optimisation; etc.

• Support transfer of existing upstream processes from customers and facilitate process development for / transfer to cGMP manufacturing.

• Have knowledge and experience with glass, stainless steel and single use fed-batch culture processes, at different scales and with different control systems, for recombinant protein production.

• Write and revise protocols, procedures, reports and other process related documentation as necessary to support upstream process development and transfer to cGMP manufacturing operations.

• Provide strong scientific and technical leadership in the identification, evaluation, and championing of new technologies for upstream process development whilst maintaining and improving established technologies.

• Demonstrate current knowledge of industry trends, practices and standards.

• Having knowledge and understanding of process characterisation and QbD principles, and of FMEA, is a plus.

Essential Skills / Qualifications:
Ideally a PhD degree in Biochemical Engineering, Biotechnology, Cell Biology, or related field.

10+ years experience in the biotech/pharmaceutical industry within a mammalian cell culture role and an excellent understanding of the theory and practice of cell culture and process development is required.

Documented solid history of technical accomplishments in the mammalian cell culture field, e.g. relevant experience in upstream process development.

Desirable Skills / Qualifications:
Experience working in a CMO environment would be a benefit, but not essential.
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