Senior Manager, Bioprocess Development Sarasota, FL (East Coast) Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team.
This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions.
We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide.
We offer an array of highly competitive benefits and perks to our valued associates.
Responsibilities: Manage the Bioprocess development group (USP and DSP), which includes research associates, scientists, and senior scientists.
Manage timelines, resources, and studies to support execution of the plan in partnership with supervisor.
Leads the effort to define, plan and execute studies to support Microbial (bacteria and yeast) process understanding and characterization to improve process robustness and product quality providing technical support and leadership Guide risk assessment and mitigation strategy development.
Oversee laboratory experimentation using bench top fermenters, homogenizers, chromatography systems, cross flow filtration, small scale expansion systems, centrifugation, as well analytical methods for in process control and release.
Develop and implement protocols and procedures that embody best practices in biologics manufacturing (cGMP, QbD).
Serve as a technical expert at bench/pilot scale and assist with technology transfer from process development to cGMP manufacturing including definition of bill of materials, sample plan, batch record drafting/review, and discrepancy resolution.
Interact with clients Write and review documentation Coordinate activities with MSAT and Manufacturing Requirements: BS in Life Sciences or Chemical or Biochemical Engineering, or other related Biological Science degree.
Experience in development of pDNA and recombinant products for cGMP manufacturing.
Minimum 5 years of experience in biopharmaceutical industry Previous work in process development and characterization in Microbial based products Experience in scaling up activities Experience with use of single use equipment (preferred) Strong interpersonal, communication (verbal and written), and organizational skills.
Hands on experience in USP and DSP operation, such as set up, sampling harvesting, configuration, process control and programing.
CGMP knowledge and experience Comfort working in fluid structure of a start-up biotech.
Independence and creative problem-solving abilities.
Ability to handle highly confidential business information.
Exceptional time management and multi-tasking skills.
Team leadership skills and team player.
Deep knowledge in statistical methodologies and DoE for process development and optimization EOE/DFW