QC Analyst - Bioassay; Temporary, 2nd shift, Wed-Sat

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

Lexington, MA

The field of gene therapy is growing rapidly. Genezen provides process development, GMP viral vectors, and cell transduction for gene and cell therapy clinical trials. This role supports the Bioassay team in a GMP laboratory on a 2nd shift (1:00 PM – 11:30 PM), Wednesday–Saturday, on-site at Genezen’s Lexington facility. All activities are conducted in accordance with cGMP guidelines and department policies.

JOB SUMMARY

The QC Analyst will be responsible for routine and non-routine QC testing within the Bioassay team. This on-site position (Mon–Fri initial period) supports daily operations through execution of cell-based testing, routine lab support, and adherence to Quality Systems. Responsibilities include in-process testing, lot release testing, and stability testing.

ESSENTIAL JOB FUNCTIONS

• Perform routine and non-routine cell-based testing and review in-process, DS, and DP release and stability samples in accordance with SOPs (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 communicate 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, with the ability to apply to various situations and identify deficiencies with some guidance.
• Adaptability to schedule changes based on business needs.
• Criminal background check required (completion by staffing agency acceptable).
• Other duties as assigned.

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

BA/BS in Biochemistry/Cell Biology or related science

ON-THE-JOB EXPERIENCE

Minimum 2 years’ laboratory experience in QC testing, preferably in a GMP environment. Thorough understanding of industry testing requirements/standards.

SKILLS / ABILITIES

Computer literacy (MS Word, Excel, and LIMS). Good communication and organizational skills, with ability to work well with others and independently.

PAY RATE

Temporary assignment via staffing agency. Anticipated pay range: $30–$40 per hour, based on qualifications, skills, and experience.

PHYSICAL DEMANDS

• Regularly sit for long periods.
• Move, stand, and use hands for manipulation; reach with arms.
• Occasionally walk, climb or balance, kneel, crouch, or crawl.
• Frequently lift up to 10 pounds; occasionally up to 25 pounds.
• Close vision and ability to focus.
• Communicate verbally and in writing.

GENEZEN'S VALUES

Committed to science, urgency for patients, resilience, excellence and integrity, and solutions-driven partnerships with our clients and colleagues.

GENEZEN'S BENEFITS

• Paid vacation days (based on tenure)
• 401(k) plan with company match up to 6%
• Choice of healthcare plans
• FSA and HSA programs
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance

ADDITIONAL DETAILS

• Genezen is an Equal Opportunity Employer and participates in EVerify.
• Genezen is not able to sponsor visas.
• Location:
  
  Lexington, MA and Fishers, IN (two locations).