Gm manufacturing ( peptides)

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 c GMP, 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

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