Manufacturing Process Engineer

Process Engineer, Akron Bio
(Sarasota, FL)

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 Process Engineer will report directly to the Sr. Manufacturing Manager at the Sarasota, FL site and be primarily responsible for providing technical guidance and support for all development and commercial manufacturing activities.
 
Responsibilities:
•    Responsible for operating, maintaining, and troubleshooting all large-scale process equipment (including but not limited to microbial fermenters, AKTA chromatography and UF/DF systems, harvest/clarification skids and mixers).
•    Working with process development, MSAT, and manufacturing on the development, tech transfer, and GMP execution of commercial batches.
•    Engaging with cross-functional teams in QA, QC and Facilities/Engineering to support projects as assigned.
•    Assisting with batch record/SOP drafting and protocol generation as needed.

Requirements:
•    BS in chemical engineering, chemistry/biochemistry, microbiology, molecular biology, or related scientific discipline. MS desirable.
•    4-5 years of experience working with medium to large scale (50 – 200 L or larger) suspension bioreactors or microbial fermenters in a process development/R&D, MSAT, or manufacturing setting.
•    Experience working with microbial cell lines and cultures (bacterial and yeast).
•    Knowledge of purification technologies (IEX, Affinity, MM, HIC) and column packing. Prior working experience with AKTA systems (Pilot, Ready, Readyflux, and Process) is highly desirable.
•    Experience working with and/or developing production platforms for pDNA, viral vectors, recombinant proteins/endonucleases, growth factors, or cytokines.
•    Experience working with TrackWise, SAP, or other electronic quality and ERP systems.
•    Working knowledge of CGMP and regulatory requirements in a biomanufacturing setting.
•    Ability to work both independently and as part of a growing team.
•    Ability to compile, analyze and interpret data.
•    Ability to function in a fast-paced dynamic team environment and balance/prioritize multiple projects.
•    Prior experience working with a CDMO is a plus.