Job Title - Manager MS&T - Analytical Development
Job Summary
Responsible for leading analytical method transfer, verification, and lifecycle management for drug substance and drug product methods across R&D, QC, manufacturing, and external sites. The role provides MS&T support for scale-up, process validation, commercialization, and post-approval changes through scientific troubleshooting, comparability assessment, method robustness evaluation, and application of advanced analytical platforms in compliance with global regulatory guidelines.
Key Result Areas
- Ensure successful analytical method transfer across R&D, manufacturing, QC, and external CRO/CDMO sites.
- Deliver scientifically sound transfer packages, including protocols, gap assessments, risk evaluations, reports, and equivalence studies.
- Establish robust acceptance criteria, system suitability, and comparability requirements to ensure transfer readiness.
- Drive timely resolution of transfer-related issues through effective troubleshooting, root cause analysis, and risk-based decision-making.
- Provide analytical support for scale-up, engineering batches, process validation, commercialization, and post-approval changes.
- Maintain lifecycle management of analytical methods through continuous monitoring, robustness evaluation, and improvement initiatives.
- Apply advanced chromatographic and characterization techniques (HPLC/UPLC/GC/GC-HS/GC-MS/LC-MS/ICP-MS/PXRD/PSD/FTIR/UV-VIS/DSC/TGA) to support method development, optimization, stability studies, impurity profiling, and extractables assessment.
- Support impurity characterization, degradation pathway understanding, and forced degradation study interpretation for product and process understanding.
- Ensure compliance with ICH guidelines, data integrity requirements, and regulatory expectations during method transfer and lifecycle activities.
- Support audits and regulatory inspections with accurate documentation, scientific justification, and compliant analytical practices.
- Ensure effective knowledge transfer between development and commercial sites to enable reliable method execution.
- Drive productivity, resource optimization, and timely execution of multiple analytical projects.
Execution of Seva (CSR) initiatives aligned with organizational goals.
Key Responsibilities
- Plan, coordinate, and execute analytical method transfer activities between internal sites and external partners.
- Prepare, review, and approve method transfer protocols, validation or verification documents, reports, and supporting technical assessments.
- Perform gap assessments, define transfer strategies, and conduct risk-based evaluations for analytical methods.
- Set acceptance criteria, comparability requirements, and system suitability parameters for transferred methods.
- Investigate transfer failures, OOS/OOT results, and method-related deviations using structured root cause analysis.
- Evaluate method ruggedness, reproducibility, and robustness, and implement corrective or preventive actions where needed.
- Use advanced chromatographic and spectroscopic techniques for analytical problem-solving, characterization, and impurity assessment.
- Provide analytical support for process validation, scale-up, engineering batches, and commercial manufacturing requirements.
- Lead technical interactions with CROs, CDMOs, QC laboratories, and cross-functional stakeholders to ensure seamless transfer execution.
- Ensure adherence to ICH Q2, ICH Q14, data integrity expectations, and internal quality systems.
- Support internal and external audits or inspections by maintaining complete, accurate, and compliant analytical documentation.
- Mentor team members on instrumentation, troubleshooting approaches, and best practices in analytical method transfer.
- Manage multiple projects, prioritize deliverables, and optimize laboratory resources for timely execution.
Required skills and Abilities
- Experience in ophthalmic / sterile dosage forms
- Exposure to CDMO tech transfer
- Hands-on experience with LIMS / Empower systems
- Leadership and ownership
- Scientific thinking and decision-making
- Strong communication and project coordination
- Attention to detail and compliance mindset
- Experience in data interpretation and impurity profiling
- Exposure to regulatory audits and dossier submissions
- Analytical thinking and problem solving
- Manages multiple projects effectively
EDUCATION AND EXPERIENCE
- Doctorate in Pharmaceutical chemistry/ analytical chemistry/ allied sciences or related subjects, from a tier-1 or tier-2 college with 8-10 Years of experience.
- M. Pharm/ M. S. (Pharm)/ M.Sc. (or Hons.)/ M. Tech in chemistry, pharmaceutical chemistry, medicinal chemistry, process chemistry or an equivalent subject, from a tier-1 or tier-2 college with 10-12 years of experience.
