Anoop Chandran — Associate Consultant

Summary: I bring scientific depth, regulatory insight, and leadership to accelerate advanced therapy medicinal products (ATMP) from early clinical development through approval and life-cycling. Specialist in CMC development for Cell & Gene Therapies/ATMPs, enabling manufacturing and Quality Control readiness. With 12+ years in analytical development supporting clinical trials, and nearly a decade working with genetically modified cells and lentiviral vectors for T-cell therapies, I combine hands-on technical expertise with strategic CMC leadership. My experience spans First-in-Human (IND, IMPD) through Marketing Authorisation and post-approval lifecycle management across the US and EU. I have supported clinical development of TCR and TIL therapies and BLA submissions for two TCR products, including TECELRA, the first approved TCR cell therapy. I apply phase-appropriate Quality by Design (QbD) principles to build robust, risk-based CMC control strategies aligned with global regulatory expectations. I am currently open to Director/Associate Director level Leadership opportunities as Employee and as CMC Technical Consultant through XCELLYTICS LTD. Core Expertise: CMC Product Development (QbD): •QTPP definition and CQA identification through criticality assessments •CPP definition using FMEA and CQA impact analysis •Phase-appropriate process & analytical control strategies •Risk-based gap assessments and QMS integration. Analytical Development & Lifecycle: •ATP-driven analytical strategies for QC/GMP testing, characterisation •Clinical phase-appropriate testing approaches •Qualification, robustness & validation studies •Controls, system suitability & reference standards •OOS/OOT investigations & Root Cause Analysis •Change Management and gap assessments, Method transfers, comparability/equivalence & change management. Scientific Expertise: •Immunology & Biochemistry •Cell-based potency assays, potency assurance strategies •Immune phenotyping & functional assays •Lentiviral vector titre & Vector Copy Number assays. CMC Regulatory Strategy and Authoring: •Author CMC (Module 3) sections for EU & US clinical and marketing applications •Analytical technical documents, comparability protocols & technical reports •Strategic regulatory responses & lifecycle management •Gap analyses & risk register development. Leadership: •6+ years leading Development teams (10–20 FTEs) •Collaborative leadership across mid-size Biotech's QC, MSAT, Regulatory, Supply Chain & Legal• Talent Hiring, development, management & team building (UK & USA)

Stackforce AI infers this person is a Healthcare expert specializing in CMC and analytical development for Cell and Gene Therapies.

Location: Didcot, England, United Kingdom

Experience: 11 yrs 9 mos