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Manager Drug Substance Manufacturing
- 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.
- 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.