Scientist, Downstream Process Development
Sarasota, 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 therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
- Work in plan definition and execute studies to support Microbial (bacteria and yeast) process understanding and characterization to improve process robustness and product.
- Guide risk assessment and mitigation strategy development.
- Execute laboratory experimentation using homogenizers, chromatography systems (AKTA), cross flow filtration, centrifugation, as well analytical methods for in process control and release.
- Prepare or oversight buffer preparation.
- Develop and implement protocols and procedures that embody best practices in biologics manufacturing (cGMP, QbD).
- Serve as a technical expert at bench/pilot scale and assist with technology transfer from process development to cGMP manufacturing including definition of bill of materials, sample plan, batch record drafting/review, and discrepancy resolution.
- Interact with clients.
- Write and review documentation
- BS or MS in a life sciences discipline.
- Must have at least 2 years of experience in an associate level PD role. This is NOT an entry level role.
- Strong interpersonal, communication (verbal and written), and organizational skills.
- Hands on experience in DSP operation, such as column packing , TFF set up, Chromatography system set up
- Experience with AKTA Systems (Explorer, Avant, Pilot)
- Experience with Repligen and Sartorius crossflow filtration systems.
- Experience with Design Expert or/and JUMP software.
- Ability to interprete analytical results to be applied to process optimization
- Comfort working in fluid structure of a start-up biotech.
- Independence and creative problem-solving abilities.
- Ability to handle highly confidential business information.
- Work in different shifts including night and weekends.
- Ability to lift more than 30 kg
- Exceptional time management and multi-tasking skills.
- Team leadership skills and team player.
- Deep knowledge in statistical methodologies and DoE for process development and optimization
- B.S. in Life Sciences or Chemical or Biochemical Engineering, or other related Biological Science degree.
- Experience in development of pDNA and recombinant products in Microbial platform for cGMP manufacturing.
- Minimum 5 years of experience in biopharmaceutical industry
- Previous work in process development and characterization in Microbial based products
- Experience in scaling up activities
- Experience with use of single use equipment (preferred)