Job Details

Responsibilities (include but are not limited to):

• 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 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 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.

Requirements

• MS degree with 0+ years of experience
• BSc degree with 2+ years 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 FreezerWorks or Freezerpro
• Basic knowledge in analytical techniques such as qPCR, ddPCR, ELISA and microbiology techniques
• Understand deep characterization knowledge in patient materials, product knowledge, and process characterization
• Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes
• Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench
• Ability to think critically, demonstrate troubleshooting and problem solving skills
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Previous experience with other technologies is a plus
• Experience with the use of Microsoft word, Excel, Power Point, Smartsheet, Prism, JMP, and other data analysis applications
• Highly collaborative with excellent interpersonal, verbal and written communication skills
• Ability to think critically with demonstrated problem-solving and troubleshooting skills
• Comfortable working in a fast-paced company environment with minimal direction and able to adjust workload/assignments based upon changing priorities
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description