10 Aug
|
Profile HR Consultants
|
Nizamabad
10 Aug
Profile HR Consultants
Nizamabad
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 executionKEY 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.- Solid leadership and team management abilityANNUAL COMPENSATION: 70LPA++Queries:Anoop Sinha-CEO, PROFILE HR CONSULTANTS PVT LTDCell- (phone hidden)
📌 Manufacturing Head- Peptides (Nizamabad)
🏢 Profile HR Consultants
📍 Nizamabad