Shrikrishna Vengurlekar
Navi Mumbai
Summary
Dynamic professional with extensive experience in API process development. Proven track record in successfully scaling up complex syntheses and ensuring regulatory compliance. Skilled laboratory and pilot plant management and chemical handling, with a strong focus on enhancing laboratory efficiency and team performance.
Overview
29
29
years of professional experience
Work History
Manager-SDL
Lysca Pharmaceuticals Pvt. Ltd
Rabale
04.2019 - 10.2023
- Development of APIs for the US market
- Total products developed are 5 APIs on lab scale, of which one is successfully synthesized up to 10 Kg level (8-step synthesis) and another one to 40 Kg scale (4-step synthesis)
- Responsible for the overall functioning of the laboratory and pilot plant (comprising two 200 L vessels and one 100 L vessel)
- Looking after all the related functions like sourcing, communication with external analytical support, manpower handling, resource management, etc
- Documentation for regulatory compliance
- Vendor development
- Defining KRAs for team members and evaluating performance through periodic reviews.
- Conduct regular project status reviews with senior management.
- Reviewing experimental data and observations, suggesting changes to improve efficiency and safety.
- Identifying the need for backward integration to improve commercial viability and reduce supply dependency.
- Conducting validation batches to generate PDR (Process Development Reports) and Tech-Transfer Reports.
- Generation of in-process, intermediate, and finished product specifications based on experimental data.
- Documentation for compliance with statutory requirements
Asst. Manager-API R&D
Ajanta Pharma Ltd.
Kandivali
12.2015 - 11.2018
- Development of a process for APIs which were successfully scaled up at plant scale; Dabigatran Etexilate Mesylate, Apremilast, Efonidipine Hydrochloride Ethanolate, Teneligliptin hydrobromide hydrate are few to name
- Conduct literature surveys for new projects.
- Identify the best RoS (Route of Synthesis) for APIs and KSMs.
- Distribute and allot work among SDL group members.
- Review experimental data and observations
- Process validation
- Cleaning validation
- Generation of specifications
- Vendor qualification
- PDR (Process Development Report and TTD (Tech Transfer Document)
- Carrying out scale-up batches at the plant
- Troubleshooting at the plant
- Inter-departmental communication
- Preparation of SOPs
Asst. Manager- (R & D)
Calyx Chemicals & Pharmaceuticals Pvt. Ltd.
Dombivli
03.2004 - 02.2014
- API development of a process for APIs that were successfully scaled up at plant scale; Flucytosine, Telmisartan, Losartan, and Isoniazid are a few to name.
- Project developed at lab scale: Venlafaxine, Artemether, Artether, Artesunate Lumefantrine, Lisinopril etc
- Worked on Grignard’s reaction, hydrogenation using Raney Ni, Pd/C Azidation etc
- Custom synthesis Worked on a 6 custom synthesis involving Azidation, Bromination, Hydrogenation, Thionyl Chloride reactions etc
- Process development
- Managing a team of 5-6 scientists
- Report preparation
- Documentation for ISO systems
- Internal audits
- Generation of specifications
- Plant scale-up to 500 kg batch size
- Handling of specialty reactants like POCl3, Thionyl chloride, sodium azide,, hydrazine hydrate etc at plant level
- Scale up and technology transfer to plants.
- Vendor qualification
- Inter-departmental communication
Self Employed (Coaching Classes)
06.2000 - 02.2004
- Coaching for XI and XII science students
Asst. Quality Control Officer
Gharda chemicals Ltd.
Chiplun
03.1999 - 05.2000
- Routine chemical analysis for finished products and raw materials as per IS.ASTM standards
Jr. Executive – R & D
Kores (I) Ltd.
Thane
04.1996 - 02.1999
- Worked on total synthesis of Theobromine
- Done scale up reactions for Theobromine
- Taken plant batches for the same
- The synthesis involves cyanation, reduction, cyclisation, selective methylation
- Worked on synthesis of ADBA, an intermediate for Ambroxol, involving bromination, oxidation etc
Analytical Chemist
Savita Chemicals Ltd.
Turbhe
10.1994 - 04.1996
- Routine chemical analysis for finished products and raw materials as per IS And ASTM standards
Education
M.Sc. - Organic Chemistry
University of Mumbai
Ratnagiri, Maharashtra05.1994
Skills
- API process development
- Custom Synthesis
- Process validation
- Regulatory compliance
- Process scale-up
- Vendor management
- Data analysis
- Laboratory and pilot plant management
- Statutory compliance for chemical laboratory
- ISO documentation
- Internal Audits
- QA documentation
- Hazardous chemical handling
- Technology transfer
References
- Dr. C. P. Bapat, Ex. Vice President, R&D, 923199228
- Dr. Kishor Kadam, Manager, API R&D, Ajanta Pharma Ltd., 9920208197
Timeline
Manager-SDL
Lysca Pharmaceuticals Pvt. Ltd
04.2019 - 10.2023
Asst. Manager-API R&D
Ajanta Pharma Ltd.
12.2015 - 11.2018
Asst. Manager- (R & D)
Calyx Chemicals & Pharmaceuticals Pvt. Ltd.
03.2004 - 02.2014
Self Employed (Coaching Classes)
06.2000 - 02.2004
Asst. Quality Control Officer
Gharda chemicals Ltd.
03.1999 - 05.2000
Jr. Executive – R & D
Kores (I) Ltd.
04.1996 - 02.1999
Analytical Chemist
Savita Chemicals Ltd.
10.1994 - 04.1996
M.Sc. - Organic Chemistry
University of Mumbai
Similar Profiles
HARSH HIREN SHAHHARSH HIREN SHAH
Sales Force Excellence - Manager at MSD Pharmaceuticals Pvt Ltd. (Payroll of Manpowergroup services India Pvt Ltd)Sales Force Excellence - Manager at MSD Pharmaceuticals Pvt Ltd. (Payroll of Manpowergroup services India Pvt Ltd)
B. KarthikB. Karthik
Area Business Manager at Ferring Pharmaceuticals Pvt. Ltd.Area Business Manager at Ferring Pharmaceuticals Pvt. Ltd.
Ratnaprabha TorawaneRatnaprabha Torawane
Sr. Officer at BDR Pharmaceuticals International Pvt. Ltd.Sr. Officer at BDR Pharmaceuticals International Pvt. Ltd.
SUSHANT KUMARSUSHANT KUMAR
Sr Manager- CNOC Team at Reliance JioSr Manager- CNOC Team at Reliance Jio
Rishi KedareRishi Kedare
Associate Manager at Morningstar India Pvt. Ltd.Associate Manager at Morningstar India Pvt. Ltd.