Website:
profileconsultants.net
Job details:
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
<career@profileconsultantsindia.com>
Cell- 9773520069
Click on Apply to know more.