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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Chief Manager - Analytical Development
Job Description
The Analytical Development Lead – Peptides is responsible for building, leading, and advancing the analytical capability for peptide programs. This role ensures robust method development, validation, analytical readiness for tech transfer, and seamless customer interaction for global peptide projects. The Lead drives scientific strategy, technical problem solving, regulatory compliance, and team development to support end to end peptide development.Doctor of Philosophy (PhD), Master of Science (MSc), MSc in Pharmaceutical and Analytical SciencesAnalytical Development, Analytical Method Development, Continuous Improvement, Instrumentation, Method Development, Method Validation, Team Leadership, Technical Knowledge
- Analytical Method Development & Validation
- Lead development of analytical methods for complex peptide molecules (HPLC/UPLC, LC–MS, GC–HS, Amino Acid Analysis).
- Implement Analytical QbD principles, including risk assessment (FMEA) and method lifecycle management.
- Perform and/or review method validation protocols, reports, and transfer packages.
- Define impurity characterization strategies (epimerization, oxidation, deamidation, peptide variants).
- Tech Transfer & Manufacturing Support
- Lead analytical readiness for plant transfers; ensure smooth movement of methods to QC.
- Support PPQ batches, change control activities and analytical troubleshooting at plant.
- Regulatory & Compliance
- Ensure strict GLP, GMP, and data‑integrity (ALCOA+) compliance across all analytical activities.
- Represent the analytical function during customer audits, regulatory interactions, and technical meetings.
- Customer / Stakeholder Interface
- Act as the primary technical SME for analytical queries from global customers.
- Lead technical discussions, responses to client questions, and CMC‑analytical sections when needed.
- Ensure customer expectations for timelines, reporting, and quality are consistently met.
- Team Leadership & Capability Building
- Lead a team of 4–6 analytical scientists; build competency matrix and training frameworks.
- Promote a culture of scientific rigor, safety, accountability, and continuous improvement.
- Instrumentation & Asset Management
- Oversee calibration, preventive maintenance, and instrument qualification schedules
- Develop a multi‑year instrumentation roadmap (LC–MS upgrades, detector strategy, AAs analyzers).
- Governance & System Excellence
- Harmonize analytical processes, templates, STPs/MOAs across ADL and partnering teams.
- Own ADL KPIs: RFT rate, OOS/OOT trends, deviation closure, method cycle time, transfer success rate.
- Drive CAPA effectiveness and analytical risk mitigation initiatives.
- Technical Competencies
- Expert in peptide analytical method development and validation (HPLC/UPLC, LC–MS, GC–HS).
- Understanding of peptide chemistry, degradation pathways, and impurity mechanisms.
- Strong knowledge of ICH guidelines, regulatory expectations, and global filing requirements.
- Hands‑on experience with troubleshooting instrumentation and analytical problems.
