Research Associate, Process Development

Research Associate, Process Development

The Research Associate, Process Development will support laboratory and manufacturing activities across both research and regulated environments. This individual will contribute to process execution, analytical testing, and documentation while working closely with cross‑functional partners to support development and scale‑up activities.

• Support the execution and qualification of analytical methods used to assess product quality and performance.
• Participate in product manufacturing activities in laboratory‑scale and cGMP environments.
• Perform in‑process, release, and characterization testing in accordance with established procedures.
• Assist in the preparation, review, and continuous improvement of manufacturing and testing documentation, including batch records.
• Draft, update, and maintain SOPs related to analytical methods, equipment operation, raw materials, and other regulated processes.
• Perform routine equipment maintenance and support qualification activities in compliance with GLP and cGMP standards.
• Maintain accurate, audit‑ready laboratory documentation in alignment with quality expectations.
• Support planning and execution logistics, including scheduling, resource coordination, and staffing for laboratory and manufacturing activities.

• Bachelor’s or Master’s degree in a scientific or engineering discipline with approximately 1–3 years of relevant industry experience.
• Hands‑on experience with mammalian cell culture in a laboratory or regulated manufacturing environment.
• Working knowledge of aseptic techniques, cell expansion, and cryopreservation workflows.
• Experience supporting equipment maintenance or qualification in a regulated environment is strongly preferred.
• Familiarity with molecular and biochemical assays is a plus.
• Experience performing immunoassays and/or cell‑based functional or imaging assays is highly desirable.
• Strong attention to detail and demonstrated ability to generate thorough, accurate laboratory documentation.
• Excellent organizational and time management skills with the ability to manage multiple priorities.

Associate

Contract

Research

Staffing and Recruiting;
Biotechnology Research