GSK - Director, Microbial Fermentation Process Development - Req. # 49832

Basic Qualifications:

 



 

• A Ph. D. in Chemical Engineering or Microbiology or Biochemistry or related field. • > 10 years of experience in the Pharmaceutical &/or Biotech. Industry. • A thorough understanding of microbial physiology and molecular biology. • Hands on experience developing fermentation processes for the production and manufacture of Bio-Pharmaceuticals using microbial expression platform(s). • Supervisory experience of having led a group of 10+ scientists and engineers. • Demonstrated leadership skills. • Ability to process and analyze complex data set. • Good technical writing skills.



Preferred Qualifications:



• Authored and reviewed multiple BLA/MAA. • Possessing detailed knowledge of regulatory requirements controlling Biotechnology drugs. • In-depth knowledge of Statistics and Statistical analysis software. • A detailed understanding of all aspects of fermentor operations and automated control systems associated with the operation of a fermentor.



Job Details:



Lead the Microbial Fermentation Process Development group. Manage day to day activities of the department. Recruit and develop staff. Set priorities for the department. Represent the Microbial Fermentation group at key matrix team and governing bodies . Responsible for all aspects of Fermentation Process Development of late stage Biopharmaceutical assets expressed using a microbial platform. Interface with Project team to set deliverables and CoG targets. Set and approve experimental plan to achieve development of commercial production process. Review data and draw conclusions that are based in good science. Responsible for all aspects of Technology Transfer of fermentation processes to the designated manufacturing group. Lead activities of matrix organized Technology Transfer Team. Interface with Global Manufacturing Supply/CMO to ensure smooth transfer of manufacturing process. Implement Design for Manufacture (DFM) principles. Responsible for all aspects CMC submissions pertaining to fermentation process development . Author and/or Review BLA and other regulatory submissions as required. Interface with the Biological New Submissions (BNS) group to assure timely and accurate submissions.





GlaxoSmithKline is dedicated to an innovative workplace and supports you with career long opportunities and learning. We offer a competitive benefits and compensation package designed to attract and retain the very best. For confidential consideration and efficient processing, visit our Web site:www.gsk.com Indicating Job Code ( Refer to Job # 49832 ) is essential to search.  Developing talent through equality of opportunity, M/F/D/V.