Research Associate/Sr. Research Associate – Process Development/Manufacturing

Cellics Therapeutics, Inc.; San Diego (CA); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Vision insurance

401(k)

Résumé du poste

A biotechnology company in San Diego is seeking a Research Associate/Sr. Research Associate to focus on downstream process development and manufacturing. The role involves designing and developing manufacturing processes for nanoparticle-based therapeutics, carrying out analyses, and ensuring compliance with cGMP guidelines. Applicants should have a background in Chemistry or related fields, with relevant experience in process development. Attractive benefits such as medical and vision insurance, and a 401(k) plan are offered.

Qualifications

• 1+ years of experience for Research Associate, or 2+ years for Senior Research Associate in a cGMP or process development environment.
• Energetic, self-motivated, able to work in a data-driven and interrogative environment.
• May be required to lift up to 25 pounds.

Responsabilités

• Design and develop scale-up Downstream processes for drug substance and drug product.
• Perform analysis of experimental data and interpret outcomes within established protocols.
• Act as the lead in daily operations ensuring all components are ready for production.
• Prepare components and accurately document data under cGMP guidelines.

Connaissances

Critical thinking

Problem-solving

Strong communication skills

Hands-on professional

Formation

Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Biology, or related field

Outils

Tangential Flow Filtration

Depth Filtration

Microfluidization

Description du poste

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)