Research Associate

Position Title: Research Associate

Work Location: Westborough, MA 01581

Assignment Duration: 3 months

Position Summary: We are seeking a highly motivated Research Associate to support the development of cell therapy products, with a primary focus on formulation and process development.

Background & Context: The successful candidate will contribute to development work on drug product, such as formulation design, manufacturing process development, product characterization, and evaluation of administration method.

Key Responsibilities:

* Support formulation development for cell therapy products, including process optimization and product evaluation.

* Conduct cell-based experiments in a laboratory setting under supervision.

* Perform basic cell culture and aseptic techniques within a biosafety cabinet (BSC).

* Assist with formulation, analytical, and manufacturing tasks involving non-cellular components as needed.

* Maintain accurate compliant experimental records in accordance with Good Documentation Practice. * Draft study protocols and reports with guidance.

Qualification & Experience:

* BS degree with 5+ years of laboratory experience or MS with 2 years.

* Hands-on experience with aseptic cell culture techniques in a BSC.

* Solid understanding of cell biology and cell-based assays. * Strong attention to detail and organizational skills. * Ability to work independently and collaborative within a team. * Self-motivated and proactive in learning new skills. * Excellent written and verbal communication skills.

* Ability to analyze experimental data and summarize findings clearly. * Flexibility to work variable hours as needed. * Prior experience working in a GMP-regulated environment is desirable.

* Knowledge and hands-on experience in drug product development.

* Knowledge and experience of CMC (Chemistry Manufacturing and Control) development.

* Familiarity with GMP standards, ICH guidelines, and global compendial regulations including USP, JP and EP.

* Prior experience with flow cytometry and plate-based assays.

* Prior experience with cryopreservation and controlled rate freezing protocols

* Prior experience with cryogenic temperature handling of biological products is desirable

* Knowledge of Quality by design, or drafting of risk assessments and FMEA is desirable * Familiarity with data analysis and visualization tools such as GraphPad Prism and JMP.

* Flexibility to work on weekends as needed.