Job Description

We are seeking a highly motivated Research Associate to support the development of cell therapy products, with a primary focus on formulation development. 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. This role involved hands-on laboratory work including cell culture, preparation of drug product, other wet lab experiments, data analysis, and documentation such as drafting protocols and reports. The Research Associate will work under the guidance of a Scientist II.

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.
• Contribute to the development and evaluation of administration procedures simutated at clinical settings.
• Maintain accurate compliant experimental records in accordance with Good Documentation Practice.
• Draft study protocols and reports with guidance.

Qualifications:
Required
• BS degree with 5+ years of laboratory experience or MS with 2 years.
• Hands-on experience with aseptic tissue 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.
• Knowledge and experience of CMC (Chemistry Manufacturing and Control) development.

Preferred
• Prior experience working in a GMP-regulated environment is highly desirable.
• Knowledge and hands-on experience in drug product 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.
• Familiarity with data analysis and visualization tools such as GraphPad Prism and JMP.
• Flexibility to work on weekends as needed.

Job Tags

Contract work, Weekend work,

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