Facility Setup Project Manager
7 days ago
About 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 seeking an experienced General Manager to embed quality-by-design during facility planning, construction, and commissioning. You will be responsible for ensuring regulatory alignment, working closely with engineering, design consultants, and government bodies to guarantee the facility is audit-ready and future-proof.
Key Responsibilities:- Facility Planning: Ensure facility design, layout, and utilities meet GMP, biosafety, and ISO standards.
- Documentation Development: Develop documentation (Facility Master File, SOPs, QA checklists).
- Regulatory Compliance: Liaise with consultants and regulators (DBT, CDSCO, local PCB, Factories Act).
- Risk Management: Drive risk assessments to prevent costly compliance errors.
- Experience: Minimum 6 years experience in Biotech/Pharma facilities projects (manufacturing, validation, audits).
- Credentials: Strong knowledge of GMP, ISO, HACCP, biosafety, and facility approvals.
- Skills: Detail-oriented professional who can balance compliance with project agility.
You'll have the opportunity to set up the commercial facility and compliance foundation for a world-class biotech platform, ensuring India takes a global lead in sustainable recombinant protein production.
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