SUNACT Cancer Institute
Website:
sunactcancer.com
Job details:
Role summary
SunAct is building India’s first fully integrated Cell & Gene Therapy ecosystem, spanning discovery, development, clinical deployment, and commercialization. This role is specifically for SunAct’s biotech arm, which is developing next‑generation oncological therapies for India and global markets.
As part of this growth, we are hiring a Scientist to lead process and analytical development activities that bridge early-stage development with GMP manufacturing readiness. This is a hands-on, translational role for someone who has taken molecules or cell therapy processes through development and successfully handed them off to manufacturing, not a role focused on discovery or early-stage innovation research.
Key responsibilities
- Design, optimize, and scale upstream and downstream processes for Cell & Gene Therapies (or mAbs), ensuring process robustness, high yield, and regulatory alignment.
- Develop, qualify, and validate analytical methods (e.g., flow cytometry, cell-based potency assays, ELISA, qPCR/ddPCR, HPLC) for identity, purity, potency, and safety testing.
- Lead or actively support tech transfer protocols, technology transfer reports (TTRs), and analytical method transfers to internal GMP manufacturing suites or partner CDMOs/contract testing labs.
- Author and review SOPs, Master Batch Records (MBRs), assay validation protocols, and technical reports to support regulatory filings and CMC documentation.
- Act as the technical SME to troubleshoot process deviations, out-of-specification (OOS) analytical results, and scale-up bottlenecks.
- Partner closely with Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, and Manufacturing teams to ensure seamless operational alignment.
Required experience
- 6–8 years of experience in process and/or analytical development of cell and gene therapies OR monoclonal antibodies (mAbs).
- Demonstrated hands-on experience in at least two of the following: process development (PD), analytical development (AD), technology transfer, or method transfer.
- Proven track record of taking a process from development through to a successful technology or method transfer into GMP manufacturing, a pilot plant, or a CDMO.
- Working knowledge of relevant analytical techniques (e.g., ELISA, flow cytometry, potency/bioassays, qPCR/ddPCR, HPLC, or equivalent, depending on modality).
- Strong technical documentation skills with protocols, reports, and transfer packages that can withstand internal and external audit scrutiny.
Qualifications
- PhD in Immunology (or a closely related field) OR
- MSc/M.Tech with 5+ years of hands-on experience in immunology-related research or development.
- GXP (GMP/GLP) experience is a strong plus.
- Prior exposure to CMC documentation, regulatory interactions, or CDMO/tech transfer partnerships is highly valued.
Why join SunAct?
- Be part of a growing biotech function within an established cancer care and research institute, contributing to India's expanding cell and gene therapy and CAR-T manufacturing capability from the ground up.
Reporting & Location
- Reports to Chief Development Officer
- Based in MBC park, Thane
Click on Apply to know more.
