Manufacturing Upstream Lead

Company: Akron Bio
Location: Sarasota
Posted on: May 7, 2022

Job Description:

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.
General Responsibilities
Responsible for training of new employees or existing team members
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, etc.

Requirements
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, etc.
Knowledge on purification process, chromatography, and non-chromatography separation units. (Chromatography, TFF, Homogenizer, microfluidizer, clarifications, centrifugation, etc)
3+ years of experience and 1+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.
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 selling skills.
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 independently.

EOE/DFW

Keywords: Akron Bio, Sarasota , Manufacturing Upstream Lead, Other , Sarasota, Florida