17 Oct
|
Gennovate
|
Mumbai
We are building a recent bioreagents business and are looking for an experienced scientific leader to take it from concept to commercial production.
This is a founding leadership role for someone who wants to build a laboratory, develop high-performance reagents, establish robust quality systems, and create a scalable manufacturing operation from the ground up.
Key Responsibilities
- Establish and lead a bioreagent development and manufacturing laboratory, including infrastructure, equipment, SOPs and safety systems.
- Develop and scale antibody conjugation processes involving fluorescent dyes, protein fluorophores and enzymes.
- Establish protocols for titration, lot release, stability testing and product quality control.
- Implement quality systems aligned with ISO 13485 requirements, including batch documentation, traceability and change control.
- Evaluate antibody clones, qualify raw-material suppliers and establish product performance specifications.
- Lead reagent validation with research laboratories and key opinion leaders, while supporting custom development projects.
- Build and mentor a scientific team, with a planned expansion to 8–15 scientists over three years.
- Work closely with leadership on product strategy, manufacturing economics and the product roadmap.
What We’re Looking For
- PhD or MSc in Immunology, Biochemistry, Biotechnology or a related discipline.
- 8+ years of relevant industry experience in antibody reagent development or manufacturing, including at least 3 years in a leadership role.
- Strong hands-on expertise in antibody conjugation, fluorescent labelling and degree-of-labelling optimisation.
- Advanced flow cytometry expertise, including titration, multicolour panel design, compensation and instrument QC.
- Experience in commercial reagent manufacturing, lot release and specification-based quality control.
- Working knowledge of GMP principles and/or ISO 13485 quality systems.
Desirable Experience
- Background with a global reagent manufacturer, CDMO or biopharma quality-control laboratory.
- Experience in ELISA, immunoassays or imaging reagents.
- Exposure to hybridoma or recombinant antibody production, reagent stabilisation or lyophilisation.
- Familiarity with IVD regulatory requirements in India or international markets.
📌 Head – Bioreagent Development & Manufacturing (Mumbai)
🏢 Gennovate
📍 Mumbai