Suresh Kumar

Results-driven API Process R&D leader with 21+ years of experience across Oncology and Non-Oncology synthetic development, spanning innovator, generic, and CDMO environments (Shilpa Pharma Lifesciences, Solara Active Pharma Sciences, Lupin, Granules OmniChem, and Apotex Pharmachem). Proven track record in Route of Synthesis (ROS) selection, process optimization, CMA/CPP identification, polymorph development, and DMF/regulatory filing support (Impurity Control Strategy, Nitrosamine and GTI evaluation).

Experience leading R&D teams of up to 20 scientists and serving as a Core Team Member through four USFDA audits. Adept at translating lab-scale chemistry into robust, cost-effective, and compliant commercial manufacturing processes for complex oncology molecules.

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)

Ph.D. - Chemistry - SRM University

M.Phil. - Chemistry - Periyar University (2009)

M.Sc. - Chemistry - Bishop Heber College (2003)

B.Sc. - Chemistry - Bishop Heber College (2001)