General Manager - Facility Setup & Compliances (Biologicals manufacturing)
Loopworm
About Loopworm:
At Loopworm, we are building the future of recombinant protein production with LoopBac technology, using insects as a reactor-free production platform. This novel process requires meticulous attention to high quality construction, biosafety, and compliance from the ground up.
The Role:
We are hiring a General Manager to embed quality-by-design during facility planning, construction and commissioning. You will be the custodian of regulatory alignment, working closely with engineering, design consultants, and government bodies to ensure the facility is audit-ready and future-proof.
What You’ll Do:
- Ensure facility design, layout, and utilities meet GMP, biosafety, and ISO standards.
- Develop documentation (Facility Master File, SOPs, QA checklists).
- Liaise with consultants and regulators (DBT, CDSCO, local PCB, Factories Act).
- Drive risk assessments to prevent costly compliance errors.
What We’re Looking For:
- Minimum 6 years experience in Biotech/Pharma facilities projects (manufacturing, validation, audits).
- Strong knowledge of GMP, ISO, HACCP, biosafety, and facility approvals.
- Detail-oriented professional who can balance compliance with project agility.
Why Join Us?
You’ll be setting up the commercial facility and compliance foundation for a world-class biotech platform, ensuring India takes a global lead in sustainable recombinant protein production.
