Assistant General Manager – Formulation R&D at Chemo India Formulations Pvt. Ltd. (2022-05 – 2025-12)
- Led formulation development, manufacturing and commercialization of multiple generic products for regulatory and semi-regulated markets.
- Managed end-to-end development activities including pre-formulation, optimization, scale-up, validation, and commercial batches.
- Successfully executed technology transfer of the site transfer products from R&D to manufacturing sites and CDMOs.
- Led and mentored a 15-member formulation R&D team, ensuring on-time project delivery.
- Reviewed literature, patent landscapes, and defined development strategies aligned with regulatory expectations.
- Provided CMC responses to regulatory agency queries within defined timelines.
- Handled Monthly Operations Review Meetings, R & D review meetings and Quality review meetings with senior management.
- Developed and commercialized for alternate vendor for API and Excipients for cost effective products.
- Coordinated with other cross-functional teams like QA, QC, RA, IP, PK, and production/Manufacturing team for smooth functioning of the product with in specified time lines.
- Overview the stability studies across multiple packaging configurations per ICH guidelines for cost reduction.
- Project management coordination, Planning/Resource management/Budgeting.
- Review of Technical documentation/Protocols/Reports/PDR etc.
- Procurement of the Materials required for development and Manufacturing through SAP.
Senior Manager – Formulation R&D at Chemo India Formulations Pvt. Ltd. (2017-06 – 2022-05)
- Led end-to-end laboratory setup & commissioning at Chemo India Formulations, with installation of the equipment's (IQ, OQ and PQ) and ensuring regulatory compliance, operational readiness, workflow optimization
- Working knowledge on documents related to cGMPs, Standard Operating Procedures.
- Developed robust formulations for solid oral and liquid dosage forms targeting regulated markets.
- Supported pivotal bio-studies, exhibit batches, and site-transfer projects.
- Actively involved in validation and commercialization of developed products. 16 no's products were commercialized to various regulatory markets.
- Additional job functional include Lab activity plan, support, coordinate and execute day to day laboratory activities, Review of Calibration of instruments, Qualification of Equipment's, maintenance of updated equipment logbooks and Equipment's maintenance.
- Lead, review of any laboratory investigations for data/deviations, OS/OOT/result/implementation of CAPA.
- Preparation and Review of Bill of Materials, Master Formula Card, Specifications & Generation of PO's for Raw Materials and Products required for Lab purpose.
Manager – Formulation Development at Airis Pharma Pvt. Ltd. (2016-05 – 2017-05)
- Led formulation development activities for generic solid oral dosage forms.
- Successfully transferred and commercialized the product at CDMO & Supported the scale-up and manufacturing transfer activities.
Manager – Formulation Development & Manufacturing & Commercial launching products at International Pharmaceutical Generics Ltd. (2014-05 – 2016-04)
- Worked on development and scale-up of generic formulations for regulated North American markets.
- Successfully commercialization of the developed products at different sites of CDMO
- Collaborated with different cross functional teams like QC, QA, Regulatory, and manufacturing teams for dossier support.
- Monitored the Formulation development and production activity at various CRO's and CDMO.
Assistant Manager – Formulation Development & Technology Transfer at Aizant Drug Research Solutions Pvt. Ltd. (2013-02 – 2014-04)
- Worked and supported the client-based formulation development activity and CDMO projects.
- Successfully site transferred the products (8 no's) from different sites to manufacturing unit with slight modifications in the process with out hampering the quality of the products.
- Involved in scale-up, exhibit batch execution, and documentation of the In-house products.
Executive / Officer – Formulation Development at Finoso Pharma Pvt. Ltd. | Granules India Ltd. (2007-09 – 2013-01)
- Led end-to-end laboratory setup with qualification of the equipment's (IQ, OQ and PQ) at M/s Finoso Pharma, and operational readiness for workflow optimization.
- Hands-on experience in formulation development for various dosage forms and pilot-scale manufacturing support.
- Successfully transferred the developed products to different CMO's.
