Senior Process Development Scientist
Company: Akron Bio
Posted on: January 26, 2023
Senior Scientist, Upstream Process Development Sarasota, FL
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.
- ResponsibilitiesProvide technical information and experimental
assay design; data analysis and management; and instrument &
- Lead design and execution of experiments
- Mentor junior staff and developing scientist team
- Set goals and prioritize activities to reach assay development
- Independently lead the day-to-day Process Development team
- Making informed decisions regarding assay development
- Report results and data to inform company development
- 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
- 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
- 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
- Interact with clients.
- Write and review documentationRequirements
- MS or PhD in a life sciences discipline.
- Experience in development of pDNA and recombinant products for
- 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
- Hands on experience in USP operation, Media and Process
Development and Optimization, and calculation of scaling up
- Experience with Eppendorf, Applikon and Ambr250 Systems
- Experience with Repligen and Sartorius crossflow filtration
- Experience with Design Expert or/and JUMP software.
- Ability to interpret analytical results to be applied to
- Comfort working in fluid structure of a start-up biotech.
- Independence and creative problem-solving abilities.
- Ability to handle highly confidential business
- 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.
Keywords: Akron Bio, Sarasota , Senior Process Development Scientist, Other , Sarasota, Florida
Didn't find what you're looking for? Search again!