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.
Candidates will be placed as I, II and III according to the degree of knowledge and experience they possess to support, perform, and/or supervise CGMP operations. A MFG Associate III is a person with sufficient and demonstrated skills, knowledge, and experience at process Unit of Operations in a CGMP environment, while the MFG Associate I requires just the proven and correct background education.
- Manufacturing operations either upstream (large-scale fermenter, incubators, shaker flasks, small scale fermenters) and/or downstream (TFF, chromatography, cell disruption, depth, and sterilizing-filtration).
- Support development and scale up of manufacturing processes.
- Aseptic processes and testing in a cleanroom environment.
- Documentation related to manufacturing procedures.
- Authoring/revision of manufacturing batch records, SOPs, work instructions, forms, logbooks and technical reports.
- Ensures compliance with applicable regulations and industry standards (e.g., FDA 21 CFR, CGMP, ISO 13485).
- Assists Scientists/Supervisors with process validation and equipment qualification where required.
- Supports deviation investigations and implementation of change controls, CAPAs and other QMS-related documentation as assigned.
- Performs other duties as assigned.
- BA/BS or AA/AS in Biology, Chemistry, Bioengineering or a related field; 1-2 years’ experience working in a life science manufacturing role highly preferred.
- Detailed-oriented with good time management and organizational skills.
- Ability to prioritize assignments in a multi-task position.
- Motivated and able to work both independently and as part of a growing manufacturing team.
- Excellent verbal communication skills.
- Basic knowledge of Outlook, Word, Excel and Software Programs.
- Requires a strong adherence to CGMPs, regulatory compliance and safety requirements, SOPs and work instructions.
- Must be able to work a flexible schedule as this is a manufacturing environment.