Hi,

Position title: Manager Manufacturing Process Operations | API Manufacturing | Peptide Production

About the Role

We are looking for an experienced Manager Manufacturing Process Operations to lead API manufacturing operations with a focus on peptide production. This role is responsible for ensuring safe, compliant, and efficient execution of manufacturing processes while maintaining the highest standards of quality, GMP compliance, and operational excellence. The successful candidate will drive process optimization, support technology transfer and scale-up activities, mentor manufacturing teams, and collaborate with cross-functional stakeholders to achieve production goals.

Key Responsibilities

- Lead and oversee peptide/API manufacturing operations in compliance with GMP, SOPs, and EHS requirements.
- Manage manufacturing processes involving solid-phase and liquid-phase peptide synthesis.
- Monitor and optimize production processes to improve quality, productivity, and operational efficiency.
- Ensure accurate review and completion of Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), Batch Packing Records (BPR), and other GMP documentation.
- Coordinate with QA, Engineering, Warehouse, and other cross-functional teams to support uninterrupted manufacturing operations.
- Drive investigations related to deviations, CAPAs, change controls, and process improvements.
- Support equipment qualification, validation, preventive maintenance,



and technology transfer activities.
- Review manufacturing performance, identify improvement opportunities, and implement lean manufacturing initiatives.
- Ensure adherence to safety practices, environmental regulations, and hazardous material handling procedures.
- Mentor, coach, and develop manufacturing personnel while promoting a culture of quality, accountability, and continuous improvement.

Qualifications

Education

- B.E. in Chemical Engineering (Required)
- M.Sc. in Organic Chemistry (Preferred)
- Ph.D. in Organic Chemistry (Preferred)

Experience

- 12–18 years of experience in peptide, API, or intermediate manufacturing operations.

Preferred Skills

- Strong expertise in solid-phase and liquid-phase peptide synthesis.
- Experience in peptide process development, scale-up, purification, and post-synthetic modifications.
- Knowledge of hybrid technologies/Molecular Hiving is an advantage.
- Hands-on experience with peptide conjugation, cyclization, PEGylation, chelation, acylation, and analytical characterization.
- Robust understanding of GMP, data integrity, manufacturing documentation, and regulatory compliance.
- Experience in preparation and review of technical documents, including IQ, OQ, PQ, and validation protocols.
- Proven ability to lead manufacturing teams, troubleshoot processes, and collaborate effectively across functions.
- Excellent communication, leadership, and problem-solving skills.

📌 Manager Manufacturing Process For API Manufacturing Peptide Production (Gujarat)
🏢 Adecco India
📍 Gujarat