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.
Robust 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.
Solid leadership and team management ability

Queries:

Anoop Sinha-CEO, PROFILE HR CONSULTANTS PVT LTD

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📌 Assistant Vice President : Peptide Manufacturing Hyderabad
🏢 Profile HR Consultants
📍 Hyderabad