GM Manufacturing ( Peptides)

Profile HR Consultants Pvt Ltd. · India

CLIENT : Global end-to-end solution provider for API Process Development for Peptides and Proteins.

Role Overview:

The Peptide Production Lead oversees end-to-end peptide API manufacturing, ensuring productivity, quality, regulatory compliance, and operational excellence. The role includes leading production teams, optimizing peptide synthesis workflows, maintaining GMP standards, and acting as a key technical interface for customer interactions during audits, queries, and project execution

KEY DELIVERABLES:

• Lead daily operations in peptide synthesis, cleavage, purification (HPLC/Prep LC), concentration, and lyophilization.
• Execute batches as per MFR/BMR and meet production timelines.
• Troubleshoot issues in SPPS/LPPS and downstream processes.
• Support tech transfers, scale-up, and process validation.
• Drive yield improvement, cycle-time reduction, and cost optimization.
• Review and approve MFRs, BMRs, SOPs, deviations, and change controls
• Ensure manufacturing aligns with cGMP, ICH, and global regulatory requirements (USFDA, EMA, MHRA).
• Maintain accurate GMP documentation and logbooks.
• Conduct RCA for deviations, OOS, and non-conformances.

Incumbent profile:

• Organic Chemistry, Biochemistry, Biotechnology qualified with leadership experience in peptide API manufacturing.
• Strong knowledge of SPPS, peptide purification, characterization, scale-up, and downstream processing.
• Mandatory hands-on exposure to GMP and regulatory environments.
• Technical expertise in peptide chemistry and downstream operations.
• Customer-facing communication skills with technical clarity.
• Strong leadership and team management ability

Queries:

Anoop Sinha-CEO, PROFILE HR CONSULTANTS PVT LTD

Cell- 9773520069