Senior Scientist, Upstream 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 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.
- Provide technical information and experimental assay design; data analysis and management; and instrument & project troubleshooting.
- Lead design and execution of experiments
- Mentor junior staff and developing scientist team
- Set goals and prioritize activities to reach assay development milestones
- Independently lead the day-to-day Process Development team work.
- Making informed decisions regarding assay development pathway.
- Report results and data to inform company development direction.
- Supporting the Process Development team in the following: time management and prioritization
- Provide feedback on experimental plans.
- Execute multiple experiments in parallel.
- Support assay development for new targets and multiplexed detection.
- Define 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 bench top fermenters, homogenizers, cross flow filtration, small scale expansion systems, centrifugation, as well analytical methods for in process control and release.
- 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
- MS or PhD in a life sciences discipline.
- Experience in development of pDNA and recombinant products for cGMP manufacturing.
- Minimum 5+ years of experience in upstream or downstream PD in an advanced contributor role.
- Previous work in process development and characterization in Microbial based products.
- Strong interpersonal, communication (verbal and written), and organizational skills.
- Hands on experience in USP operation, Media and Process Development and Optimization, and calculation of scaling up parameters.
- Experience with Eppendorf, Applikon and Ambr250 Systems
- Experience with Repligen and Sartorius crossflow filtration systems.
- Experience with Design Expert or/and JUMP software.
- Ability to interpret 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
- Experience in scaling up activities.