Boca Raton, FL (East Coast)
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 and gene therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates. Responsibilities:
- Supports all technical writing requirements for manufacturing/operations.
- Author and revise manufacturing batch records, SOPs, work instructions, validation/qualification protocols, forms, logbooks, technical reports, CAPAs, change controls and any other document that may apply.
- Formulate, fill and finish buffer and media for microbial an mammalian process (Upstream and Downstream processing)
- Perform aseptic processes in a controlled or cleanroom environment.
- Perform in-process testing of products using general laboratory equipment/instrumentation.
- Utilizes formulas, work instructions or equivalent to monitor the production process.
- Perform experiments associated with development, improvement and scaling up or optimization of manufacturing and development processes.
- Troubleshoot problems associated with equipment, process development/production/ including data analysis and internal record keeping.
- Perform Environmental Monitoring activities as required.
- Perform the clean-zone cleaning as required.
- Maintains current knowledge of developments related to product recovery and purification processes.
- Performs duties in accordance with established laboratory standards.
- Evaluate, troubleshoot and solve routine problems. Interprets data based on knowledge and experience.
- Perform process validation and equipment qualification as required.
- Perform general equipment preventive maintenance. Contribute to maintaining lab and equipment cleanliness.
- Support and coordinate deviation investigations and implementation of change controls or robust corrective and preventative actions.
- Support finished product labeling, raw material aliquoting and, re-labeling requirements when necessary.
- Perform other duties as assigned.
- 2 years minimum relevant experience.
- Detailed oriented with good time management and organizational skills.
- Ability to work well under pressure and prioritize assignments in a multi-task position.
- Motivated and able to work independently.
- Excellent verbal communication skills and people/customer service oriented.
- Basic knowledge of Outlook, Word, Excel and Software Programs.
- Requires a strong adherence to cGMPs, regulatory compliance and safety requirements, SOPs and other related documents such as SDS and manuals