QC Analyst II​/III - Analytical

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.

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.

The QC Analyst II/III will be responsible for routine and non‑routine QC testing according to Standard Operating Procedures (SOPs) in a GMP laboratory. This position is based at Genezen’s state‑of‑the‑art facility in Lexington, MA, and supports daily and occasional 2nd shift or weekend operations within the Quality Control group via execution of analytical testing and Quality Systems. Activities include in‑process, release, and stability testing, deviations, corrective and preventive actions (CAPAs), investigations, out‑of‑specifications (OOS), and change controls, all performed in accordance with cGMP guidelines.

• Perform routine/non‑routine testing and review of in‑process, DS and DP release and stability samples in accordance with SOPs (q‑PCR, HPLC (SEC, IEX, rpHPLC), ELISA, RI, HIAC, DLS, Osmolality, Western Blot, CE‑SDS, etc.).
• Act as a subject‑matter expert for assay data review with minimal errors.
• Work effectively in internal/cross‑functional teams as an active member.
• Train and execute assays cross‑functionally to support release deadlines.
• Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required.
• Generate, revise, and review protocols and reports as required.
• Apply regulations to any situation, identify deficiencies, and recommend solutions with minimal guidance.
• Maintain standard operating procedures.
• Identify deviations to procedure, conduct investigations, and manage change controls, CAPAs, OOSs, and OOTs.
• Communicate gaps to key stakeholders promptly and proactively.
• Support internal and external audits as required.

• Adaptability required as work schedule may change based on business needs.
• Flexibility to support 2nd shift STAT testing on a monthly rotational basis, which may include holidays.
• Criminal background check required.
• Other duties as assigned.

• BA or BS in Chemistry, Biochemistry or related science.

Minimum 2–5+ years (Analyst II) and 5–8+ years (Analyst III) of laboratory‑based experience within QC testing capacity, preferably in a cGMP environment.

High proficiency in HPLC methods and analysis, as well as other analytical methods.

Follow procedures and complete documentation applying cGMP/GDP/ALCOA+.

• Thorough understanding of industry testing requirements/standards.

• Computer literacy (MS Word, Excel, and LIMS).
• Good/effective communication, organizational, and critical thinking skills with the ability to work well with others and independently.
• Identify gaps and propose solutions.

The annual salary range for this position is $80,000–$100,000.

• Regularly sit for long periods of time.
• Frequently required to stand, sit, walk, balance, stoop, kneel, crouch, use hands to finger, handle, or feel, reach with hands and arms.
• Occasionally required to walk, climb or balance, and stoop, kneel, crouch, or crawl.
• Frequently lift and/or move up to 10 pounds; rarely lift and/or move up to 25 pounds.
• Frequently utilize close vision and the ability to adjust focus.
• Frequently communicate by talking, hearing, using telephone and e‑mail.

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