Manufacturing Upstream Lead
Company: Akron Bio
Posted on: May 7, 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.
The Manufacturing Upstream Lead position reports to the Manager,
Manufacturing at the Akron Sarasota campus. Prior experience in
CGMP manufacturing, operation of process equipment and aseptic
technique is prerequisites. The Manufacturing Upstream/Downstream
lead is responsible for supporting the overall CGMP manufacturing
process, through the application of broad knowledge of theories and
principles utilized to solve operational, as well as routine tasks
in the production of bulk biologics from microbial fermentation for
Phase I/II & commercial CGMP manufacturing.
Responsible for training of new employees or existing team
Generate and revise internal and external documents (SOPs, BRs)
Support initiation and closure of deviations; may serve as the lead
in the departmental investigation and be responsible for closing
out deviations and CAPAs
Troubleshoot process and equipment problems; Work with Facilities
and Validation to maintain manufacturing equipment
Performs and monitors day to day manufacturing operation activities
and verifies compliant execution with cGMP standards and procedures
from the cGMP manufacturing areas.
Provide resources and subject matter expert (SME) input to support
continuous improvement, capital, and corporate initiatives.
Interact with other departments for technological transfer,
sampling plans, material specifications, material inventory,
process development, quality events, validations, room readiness,
Prior experience in CGMP manufacturing, operation of process
equipment and aseptic technique.
Knowledge on fermentation processes at different scales and
systems: Single use fermenters, shaker flasks, SS fermenters,
Knowledge on purification process, chromatography, and
non-chromatography separation units. (Chromatography, TFF,
Homogenizer, microfluidizer, clarifications, centrifugation,
3+ years of experience and 1+ years demonstrated leadership
capability in a pharmaceutical and/or manufacturing
Demonstrated experience leading large complex programs with
external and internal customers.
Outstanding written and verbal communication skills.
Proficiency MS Office.
Execute tasks in a timely manner without direct supervision.
Proven ability to win new business through the use effective
Ability to generate and follow up on leads to close business.
Ability and enthusiasm to work within a startup environment which
means wearing multiple hats and finding solutions
Keywords: Akron Bio, Sarasota , Manufacturing Upstream Lead, Other , Sarasota, Florida
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