Research Associate - II

Job Title

Job Responsibilities:

• Execute ELISA and/or PCR testing on a regular basis or as needed, in support of process development and product characterization

• Perform data analysis, data reporting, and further statistical analysis with advanced analysis software

• Assist in data verification to ensure data integrity

• Implement reagent titration, lot-checking, and maintain proficiency testing database

• Transfer ELISA and/or PCR assays from the method development group to the analytical testing group

• Develop templates for standard operating procedures and analytical test methods

• Write, review and edit accurate technical documents

• Assist in developing, qualifying, executing, and documenting PCR methods to study and characterize processes for the production of T cell therapies

• Provide user training on instruments, sample analysis, and cross-train analysts on analytical methods

• Coordinates activities for members of project teams in the initiation and execution of laboratory experimentation

• Participate in sampling and study plan meetings to support different functional areas within Process Development

• Additional responsibilities may be assigned to reflect changes in business processes.

Required Qualifications:

• MS degree with 0+ years of experience

• BSc degree with 2+ years of industry experience in cell therapy or related area.

• HS Diploma with 5+ years’ experience also considered.

Additional Qualifications:

• Demonstrated in-depth knowledge of ELISA or PCR method development, and technical knowledge of instruments, method controls, and experience with reagent inventory management systems such as Freezer Works or Freezerpro

• Basic knowledge of analytical techniques such as qPCR, ddPCR, ELISA, and microbiology techniques

• Understand deep characterization knowledge in patient materials, product knowledge, and process characterization.