Assistant General Manager (AGM) – API Process R&D - Shilpa Pharma Lifesciences Ltd. - Raichur, India
(2024-07)
- Lead process R&D for Oncology and Non-Oncology API molecules within a 20-scientist team, driving route selection through literature search, norms preparation, and RMC calculation.
- Direct feasibility studies for Route of Synthesis (ROS) selection and single-variable process parameter optimization.
- Identify Critical Material Attributes (CMA) and Critical Process Parameters (CPP) via tolerance studies and simulation experiments.
- Oversee polymorph development and solid-state characterization (PXRD, IR, DSC) supporting NCE-I (Para-IV) filings.
- Finalize specifications for raw materials, intermediates, in-process controls, and finished products per ICH and pharmacopeial guidelines.
- Drive DMF submission readiness — Impurity Control Strategy, Nitrosamine Evaluation, and Genotoxic Impurity Evaluation (GTI) reports — and lead Deficiency Letter (DL) responses.
- Key products: Acalabrutinib maleate, Abemaciclib, Alectinib HCl, Apalutamide, Docetaxel (Trihydrate & Anhydrous), Paclitaxel, Gemcitabine, Temozolomide, Decitabine, Cabazitaxel, Mycophenolate Mofetil/Sodium, and more.
Senior Group Leader – API Process R&D, Synthetic Development - Solara Active Pharma Sciences Pvt. Ltd. - Chennai, India
(2020-05 - 2024-07)
- Led a team of 8–10 scientists in process development, selecting synthetic routes on novelty, safety, cost, green chemistry, and scale-up criteria.
- Directed feasibility and Proof-of-Concept studies to validate Route of Synthesis and optimize process parameters.
- Managed spectral elucidation (1H NMR, 13C NMR, IR, Mass) and reference standard preparation for raw materials, intermediates, impurities, and finished products.
- Supported DMF submissions (Impurity Control Strategy, Nitrosamine/GTI reports) and Deficiency Letter responses.
- Reviewed Batch Production Cumulative Reports and Equipment Mapping charts; delivered process training to production teams and provided technical support during plant qualification/validation.
- Key products: Rotigotine, Mycophenolate Mofetil, Amifampridine phosphate.
Manager (M2) – Research & Development - Lupin Ltd. - Visakhapatnam, India
(2016-05 - 2020-04)
- Headed the R&D laboratory (12-member team), driving process development and improvement for DMF-filed API molecules to optimize yield and RMC.
- Prepared and reviewed Process Development Reports, Investigation Reports, and department SOPs; supported plant deviation and QC OOS/OOT investigations.
- Established solvent, catalyst, and raw material/intermediate recovery programs for exhibit and commercial-scale products.
- Provided regulatory support for DMF filings and queries; reviewed BPR, validation, and stability protocols/reports.
- Key products: Dolutegravir sodium, Raltegravir potassium.
Manager – Research & Development - Granules OmniChem India Pvt. Ltd. - Visakhapatnam, India
(2015-03 - 2016-05)
- Absorbed and implemented processes transferred from the Global Technology Transfer team into plant operations.
- Provided investigation and troubleshooting support for plant operations; reviewed Technology Transfer documents, BPR, and equipment mapping/validation reports.
Group Leader → Scientist – Process R&D - Apotex Pharmachem India Pvt. Ltd. - Bangalore, India
(2005-03 - 2015-03)
- Progressed from Scientist to Group Leader (team of 4–7) over a 10-year tenure in process R&D.
- Collaborated with the Global R&D team on synthetic route selection, patent/patentability assessment, and organic synthesis using TLC and column chromatography.
- Delivered NCE-I (Para-IV) polymorph development, CMA/CPP identification, and reaction calorimetry (RC)/ARSST support for scale-up risk assessment.
- Prepared cost sheets, Technology Transfer packages, MPDR, RSM, and GTI reports supporting DMF submissions and DL responses; trained teams on GLP and lab safety.
- Key products: Rizatriptan benzoate, Zolmitriptan, Ivacaftor, Fingolimod Hydrochloride, Gatifloxacin hydrochloride, Dronedarone Hydrochloride.
Trainee Scientist – Drug Discovery - Jubilant Biosys Limited - Bangalore, India
(2004-03 - 2005-02)
Junior Research Fellow – DRDO Project - Loyola College - Chennai, India
(2003-07 - 2004-02)
