Role details

Manager Drug Substance Manufacturing

Chicago   •   USD115,000 - USD120,000   •  Permanent

Bullet points

  • Biosimilars Manufacturing Company Seeking Manager Drug Substance Manufacturing
  • Come work for a company that puts you in the driver seat

About Our Client

My client is an innovative, biosimilar start-up with strong financial backing focused on developing recombinant proteins and antibody products for major regulated markets globally. Their vision is to make biosimilar medications affordable.

Job Description

  • Manager Drug Substance Manufacturing will oversee and schedule fermentation and cell culture operations and personnel within cGMP guidelines.
  • Troubleshoots complex manufacturing process problems. Leads the fermentation and cell culture team to identify issues and propose adequate solutions.
  • Ensure that all projects are executed properly, attaining desired outcomes on schedule and meeting quality standards.
  • Ensure that employees performing fermentation and cell culture operations have obtained proper training on fermentation and cell culture methods, cGMP guidelines, and SOP's.
  • Responsible for training manufacturing personnel on the use of the Batch records, scheduling, ordering of raw materials, setting up production batches, and maintaining media/buffer inventory.
  • Responsible for writing/reviewing fermentation and cell culture batch records, purification batch records, reviewing SOP's pertaining to fermentation and cell culture processes and equipment and purification processes and equipment, writing/reviewing User Requirement Specifications (URSs) in preparation for the ordering and receiving of equipment to be used in the fermentation cell culture and purification processes.
  • Analyze data and results and provide conclusions and proposals.
  • May operate production equipment and prepare buffers and media, inspect, label, or box.
  • Work with Manufacturing, Regulatory and Quality, Engineering and Technology groups on issues and identifies process improvement opportunities.
  • Work on small projects as assigned and generate technical reports.
  • Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate, disciplining and recommending termination when necessary.

The Successful Applicant

  • Bachelor's degree Life Sciences discipline or equivalent,
  • Masters degree strongly
  • 7-10 years' relevant experience in manufacturing or laboratory experience
    • including process development, optimization, scale-up, cGMP and supervisory experience.
  • Drug substance or biotech experience
  • Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
  • Experience with FDA audits and participation in BLA fillings is desirable
  • Managing multiple projects
  • Writing procedures and protocols

What's on Offer

This is a choose your adventure environment offering a very competitive base salary + strong benefits.

Apply for this job

Click the Apply or LinkedIn button below or contact Xavier Durrant quoting job reference 1202787
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