Unknown Company
Research Associate/Sr. Research Associate – Process Development/Manufacturing
Cellics Therapeutics is a rapidly growing biotech company developing novel therapeutics for inflammatory and infectious diseases based on the award-winning Cellular Nanoparticle technology. Cellics offers a highly motivational and rewarding work environment with attractive salary and benefits.
Base pay range
$70,000.00/yr - $90,000.00/yr
Annual Bonus and Stock options
About the Role
We are seeking a Research Associate/ Senior Research Associate of Downstream process development/manufacturing to join the CMC team. The candidate will contribute to the design and development of the manufacturing process and the manufacturing of DS/DP to support the pre-clinical and clinical trial studies.
Responsibilities
- Design and develop scale-up Downstream process for manufacturing nanoparticle-based drug substance and drug product.
- Perform analysis of experimental data and interpret immediate experimental outcomes and/or conclusions within established protocols.
- Act as the lead in daily operations ensuring all components are in place and all documentation is complete prior to finishing a campaign.
- Act as SME (subject matter expert) for a specific piece of equipment.
- Schedule and execute manufacturing tasks under cGMP guidelines.
- Troubleshoot manufacturing processes under cGMP guidelines and under the supervision of manufacturing supervisor.
- Assist in the research and implementation of new methods and technologies to enhance operations.
- Prepare components, buffers, and other solutions as needed.
- Accurately document data and write/review batch records under cGMP guidelines.
- Reliably execute and write well defined SOPs and manufacturing batch records.
- Initiate and write revisions to current GMP/SOP guidelines.
- Responsible for routine maintenance of production equipment and production suites.
Requirements
- Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Biology, or related field.
- 1+ years of experience (for RA), or 2+ years experience (for Senior RA) working in a cGMP or process development environment strongly preferred.
- Experience in Tangential Flow Filtration, Depth Filtration, and Microfluidization.
- Strong critical thinking and problem-solving skills.
- Energetic, positive, self‑motivated, and hands‑on professional with strong work ethics, able to work both independently and with a team in an intense, data‑driven, and interrogative environment.
- Strong written and verbal communication skills.
- May be required to lift up to 25 pounds.
Benefits
- Medical insurance
- Vision insurance
- 401(k)