QC Manager – Cell Therapy

Biopatrika; Haryana; In loco; INR 2.500.000 - 4.000.000; Tempo pieno

Descrizione del lavoro

East Ocyon Bio in Gurugram, India, seeks an experienced QC Manager to lead a growing quality control function for GMP cell therapy manufacturing. You will oversee the QC team, ensure robust data integrity, and drive method qualification and tech transfer to enable timely batch release.

The role requires 7–10 years of QC experience in biopharma or similar GMP settings, with strong GMP knowledge and leadership capabilities. On-site in Gurugram, India.

Competenze

• 7–10 years of QC experience in biopharma, cell or gene therapy, or another GMP environment.
• Proven experience supervising a QC team.
• Strong grounding in GMP, quality systems and analytical data review.

Mansioni

• Lead a team of QC analysts and scientists.
• Oversee release and in-process testing: flow cytometry, cell-based potency assays, qPCR/RT-qPCR, ELISA, viability and identity/purity.
• Own first- and second-level data review ensuring GDP and ALCOA+ data integrity.
• Manage deviations, OOS/OOT investigations, CAPA and change control.
• Drive method qualification, validation and transfer.
• Collaborate with QA, Manufacturing, PD, MSAT and Regulatory to support batch release and tech transfer.

Conoscenze

QC team leadership

Data review & ALCOA+

GMP knowledge

Analytical testing

Formazione

MSc/MTech/BTech/PhD in Biotechnology/Life Sciences

Strumenti

LIMS

Descrizione del lavoro

We’re Hiring: QC Manager – Cell Therapy At East Ocyon Bio, we’re building next-generation, off-the-shelf CAR-NK cell therapies for cancer. We’re looking for an experienced QC Manager to lead our Quality Control function as we scale GMP manufacturing. No. of Positions- 01

What you’ll do:

• Lead, mentor and plan the work of a team of QC analysts and scientists
• Provide technical oversight of release and in-process testing: flow cytometry, cell-based potency assays, qPCR/RT-qPCR, ELISA, viability and identity/purity
• Own first- and second-level data review, making sure GDP and ALCOA+ data integrity are followed
• Manage deviations, OOS/OOT investigations, CAPA and change control
• Drive method qualification, validation and transfer
• Work with QA, Manufacturing, PD, MSAT and Regulatory to support batch release and tech transfer

What we’re looking for:

• 7–10 years of QC experience in biopharma, cell or gene therapy, or another GMP environment
• Proven experience supervising a QC team
• Strong grounding in GMP, quality systems and analytical data review
• M.Sc. / M.Tech / B.Tech / Ph.D. in Biotechnology, Microbiology, Biochemistry, Life Sciences or a related field
• Bonus: Skillset for immune cell characterization, viral vector analytics, LIMS Operations

Location:

• Gurugram, India

If you want to build a QC function from the ground up and help bring new cancer therapies to patients, we’d love to hear from you.