QC Analyst - Bioassay (Temporary, 2nd shift, Wed-Sat)

About this role

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The QC Analyst will be responsible for routine and non-routine QC testing within the Bioassay team within a GMP laboratory. This is a 2nd shift, Wednesday-Saturday, fully on-site, position (1 – 11.30pm) based at Genezen’s new state-of-the-art facility in Lexington, MA. This role supports daily operations within the Quality Control group through execution of cell-based testing, routine lab support and working within Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Support outside of standard shift hours is required occasionally and the initial work period will be on Mon-Fri. All activities are executed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

ESSENTIAL JOB FUNCTIONS

• Perform routine/non-routine cell-based testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, ddPCR, cell culture, ELISA)

• Perform peer review as SME of assay data with minimal errors.

• Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required.

• Review/generate protocols and reports, as required.

• Establish, revise, review and maintain standard operating procedures.

• Promptly and proactively communicates gaps to leadership

• Work as an active member of internal/cross-functional teams

• Train other analysts, as required.

SPECIAL JOB REQUIREMENTS

• Strong understanding of GxP regulations, ability to apply to any situation, and identify deficiencies w/ some guidance.

• Adaptability required as work schedule may change based on business needs.

• Criminal background check required (completion by staffing agency satisfies this requirement).

• Other duties as assigned.

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BA/BS in Biochemistry/Cell Biology or other related science

Essential

ON-THE-JOB EXPERIENCE

Minimum 2 years’ laboratory base experience within QC testing capacity, preferably in cGMP environment.

Essential