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.
This position is responsible for guiding the execution, resources, business processes and tech transfer for either the upstream or downstream groups within the MS&T department at our Sarasota Manufacturing site. This role will report to the SR MSAT Engineer and work closely with a team of Engineers and Scientists that lead tech transfer projects and will collaborate with Process Development and Manufacturing to ensure projects are executed efficiently and in a timely manner.
- Observe new commercial product introduction from Process Development Process Performance Qualification through Process Validation Activities.
- Establish and maintain the procedures, business processes and tools/systems for tech transfer.
- Assist with new clinical product introduction and guide efforts to ensure successful tech transfer through collaboration with Process Development.
- Collaborate plans with SR. MSAT Engineer on strategies to ensure successful cGMP production by actively collaborating with manufacturing operations, quality, and supply chain.
- Establishes and maintains the procedures, business processes and tools for downstream tech transfer.
- Assist SR. MSAT Engineer with multi-disciplinary cross-functional projects.
- Provides technical assistance to tech transfer programs and personnel.
- MS or BS in Science or Engineering with a minimum of 5-7 years industry experience.
- Must have demonstrated biologics expertise in upstream or downstream processing and operations.
- Expertise with technical transfer and scale up is required.
- Experience with single use technology applicable to technologies such as: fermentation, filtration, chromatography, etc.
- Experience with GMP compliance.
- Solid understanding of Process Development and cGMP production operations.
- Proven technical expertise in upstream or downstream biologics and have strong knowledge of industry best practices.
- Data analytics experience with JMP or similar program is preferred.