Research fellow - and biology

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.