Asst General Manager Peptide Process Development

• You will be joining a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry's chemistry needs. The organization has a global presence in over 80 countries, with a significant portion of revenues coming from exports to key markets such as the US and Europe.As part of your role, your key responsibilities will include:- Designing and optimizing solid-phase peptide synthesis (SPPS), solution-phase, and hybrid synthesis processes.- Developing scalable, robust, and cost-effective manufacturing routes for therapeutic peptides.- Evaluating and implementing novel chemistries to enhance production processes.You will also be expected to:- Lead lab-to-plant scale-up processes and ensure successful technology transfer to manufacturing teams.- Troubleshoot technical issues during scale-up, validation, and commercial manufacturing phases.In addition, you will be responsible for:- Preparing and reviewing regulatory documents such as development reports, BPR, and CMC sections of DMFs.- Supporting USDMF, CEP, and ROW filings, and addressing regulatory queries effectively.To be successful in this role, you should have:- A Ph.D. in Organic Chemistry, Peptide Chemistry, Pharmaceutical Sciences, or a related field.- Over 10 years of experience in peptide R&D within a generic API setting.- A proven track record of DMF support, technology transfer, and regulatory compliance.- Knowledge of Quality by Design (QbD), ICH guidelines, and cGMP requirements.Your annual compensation for this position is in the range of 25-30 LPA.For any queries or further information, you can reach out to Anoop Sinha, Director at PROFILE HR CONSULTANTS PVT LTD, at

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• Asst General Manager Peptide Process Development (Phd)

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Regulatory Compliance, Quality Standards, Technology Transfer, Stability Studies, Project Management, Leadership, Communication, Innovation,Nasal Sprays, Soft Mist Inhalers, Literature Search, Formulation Strategies, Development Batches, Scaleup, Packaging Material Evaluation, Technology Transfer Documents, Good Laboratory Practices GLP, Good Manufacturing Practices GMP, Stability , Validation Batch Manufacturing, Regulatory Submission, Drug Product Approval, Regulatory Knowledge, ProblemSolving

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validation, tech transfer, troubleshooting, regulatory filings, interpersonal skills, project management,scientific leadership, upstream processes, CMC strategy, scaleup, product investigations, experimental planning, CMC documentation, health agency queries, inspections, riskbased approaches, collaborative teamwork, audits

Regulatory Compliance, Quality Standards, Technology Transfer, Stability Studies, Project Management, Leadership, Communication, Innovation,Nasal Sprays, Soft Mist Inhalers, Literature Search, Formulation Strategies, Development Batches, Scaleup, Packaging Material Evaluation, Technology Transfer Documents, Good Laboratory Practices GLP, Good Manufacturing Practices GMP, Stability , Validation Batch Manufacturing, Regulatory Submission, Drug Product Approval, Regulatory Knowledge, ProblemSolving

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Mentoring, Project management, Technology commercialization,Handling probiotic cultures, Isolation , purification of probiotic strains, Scaling up production, Encapsulation processes, Developing probiotic unpacking profiles, Invitro modeling, Scientific development, IP applications, Managing innovation projects, Optimizing process performance, Regulatory aspects, Good Laboratory Practices GLP, Documentation , submission, Spray drying , freeze drying techniques, Watersoluble formulations

validation, tech transfer, troubleshooting, regulatory filings, interpersonal skills, project management,scientific leadership, upstream processes, CMC strategy, scaleup, product investigations, experimental planning, CMC documentation, health agency queries, inspections, riskbased approaches, collaborative teamwork, audits