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.
- Responsible for training department personnel on equipment operation, cGMPs, documentation, technical applications and equipment, etc.
- Prepare, review and execute Batch Records.
- Prepare and Review documentation (Standard Operating Procedures (SOPs), Logbooks for completeness, clarity, accuracy and submit edits to documents for revision as required.
- Responsible for reviewing, writing, and executing validation production records. Give support to Validation Department for proper validation execution
- Directs the manufacturing activities.
- Responsible for ensuring product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices.
- Responsible for compiling and analyzing trend data, preparing reports and making recommendations for changes and/or improvements.
- Author deviations, change controls, CAPAs, and reports.
- Support process development and optimization activities independently or with minimal guidance.
- Schedule production and coordinate/order/track/inventory raw material needs.
- Directly hire, train, supervise and schedule staff.
- Responsible for investigating and troubleshooting process, systems and equipment issues.
- Responsible for training/mentoring new hires within the department.
- This role will need to liaise with process development, QA, QC, and other departments to foster effective communication, technology transfer and achievement of goals.
- BS in Biology, Biotechnology, Chemical Engineering or a related field is required.
- A minimum of 7 or more years of professional experience in manufacturing for biotech, biopharmaceutical (USP and DSP, Microbial preferred)
- Knowledge of and experience working with GMP regulations and manufacturing processes is required.
- Strong organizational skills and attention to detail.
- Able to work effectively in a fast-paced, small start-up company environment.
- Self-motivated, self-disciplined and able to function independently as well as part of a team.
- Coordinate activities across multiple departments to communicate about or resolve issues and non-routine equipment events.
- Ability to represent organization in front of customers and inspectors when required.
- Ability to lead GMP training for new and current employees.