Process Development Scientist (USP)
Company: Akron Bio
Posted on: May 14, 2022
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.
Work in plan definition and execute studies to support Microbial
(bacteria and yeast) process understanding and characterization to
improve process robustness and product.
Guide risk assessment and mitigation strategy development.
Execute laboratory experimentation using bench top fermenters,
homogenizers, cross flow filtration, small scale expansion systems,
centrifugation, as well analytical methods for in process control
Prepare or oversight media and buffer.
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
Strong interpersonal, communication (verbal and written), and
Hands on experience in USP operation, Media and Process Development
and Optimization, and calculation of scaling up parameters.
Experience with Eppendorf, Applikon and Ambr250 Systems
Experience with Repligen and Sartorius crossflow filtration
Experience with Design Expert or/and JUMP software.
Ability to interpretate analytical results to be applied to process
Comfort working in fluid structure of a start-up biotech.
Independence and creative problem-solving abilities.
Ability to handle highly confidential business information.
Work in different shifts including night and weekends.
Ability to lift more than 30 kg
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
Education and Experience:
B.S. in Life Sciences or Chemical or Biochemical Engineering, or
other related Biological Science degree.
Experience in development of pDNA and recombinant products for cGMP
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)
Keywords: Akron Bio, Sarasota , Process Development Scientist (USP), Professions , Sarasota, Florida
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