Open to opportunities

Atul Shinde

@atulshinde

Project management and formulation development leader, guiding complex regulated drug programs from concept through launch.

India

Message

What I'm looking for

I’m looking to lead complex, regulated product programs end-to-end—owning stage-gate governance, cross-functional alignment, risk mitigation, and launch readiness—while mentoring teams and delivering measurable business value through strong PM and formulation expertise.

I’m an effective communicator and self-starter with more than 17 years of experience across formulation research & development (FR&D) and project management (PM). I lead cross-functional teams to drive end-to-end delivery—from kickoff to regulatory approval/launch—while staying deeply analytical about risks, timelines, budgets, and resources.

As Deputy General Manager in Project Management, I spearhead new product development and commercialization for Oral Solid Dosage Forms, DPIs, MDIs, Nebulizer products, Oral Liquids, Semisolids (pharma & cosmetics), and Injectables across the US, EU, ROW, HK, India, and CN markets. I build full-scale project plans with defined milestones, run stage-gate governance, and use FMEA, Root Cause Analysis, and Ishikawa diagrams to identify risks and drive mitigation actions.

I also focus on business development and long-term value creation through competitor insights and building/maintaining key client relationships. I’ve delivered measurable outcomes such as ensuring launch of 10+ new products per year, implementing stage gate and PM tracker systems for accountability, running product regularization drives, and bringing 25+ products through in-house/loan license arrangements to improve control, quality, and financial performance.

Experience

Work history, roles, and key accomplishments

Current

Deputy General Manager (PM)

Current

Glenmark Pharmaceutical Ltd.

Apr 2023 - Present (3 years 3 months)

Lead a project management team for India and global proprietary product portfolios, managing end-to-end development through launch for OSD, DPI, MDI, oral liquids, semisolids, and injectables. Oversee stage-gate governance, risk identification/mitigation (FMEA/root cause/Ishikawa), and cross-functional coordination for regulatory approval and commercialization.

Project Management Root Cause Analysis Ishikawa Diagrams Governance & Compliance Cross Functional Team Leadership Cross Functional Program Management

Senior Project Manager (Development)

Cipla Ltd.

Aug 2019 - Mar 2023 (3 years 7 months)

Manage development projects for hormone and oncological liquid, lyophilized, and liposomal injectable products, including CMO execution and regulatory submissions. Handle global deficiencies and oversee end-to-end SU/EB completion and ANDA submissions for multiple products per year.

Project Management Regulatory Submissions SU EB Completion Solid Semisolid Parenteral Development

Manufacturing Technology Scientist

Bright Future Pharmaceutical Laboratories Ltd.

Nov 2011 - Apr 2019 (7 years 5 months)

Lead FR&D and PM team activities to meet HK/China/US product targets and support development milestones. Manage scale-up and technology transfer for multiple products, contribute to stage gate and quality risk processes, and support lab setup/qualifications and filings including China patents.

FR&D Team Management Project Management Scaling Technology Transfer Lab Setup & Qualifications Control Drug Handling & Storage License Support Semisolid Manufacturing Support ANDA Development (Scale Up Stage)Quality Risks Patents

Junior Manager, FR&D (US Market)

Dr. Reddy’s Laboratory Ltd.

Feb 2010 - Oct 2011 (1 year 8 months)

Support development, scale-up, and optimization batches for delayed release capsule formulations, and develop semisolid formulations for the US market. Participate in development and filing of delayed release capsule and Para IV (non-infringing) delayed release capsule/ointment formulations.

Formulation Development Scale Up & Optimization Delayed Release Capsules Semi Solid Formulations Regulatory Filing (ANDA)Para IV (Non Infringing) Development Market Development

Research Associate (FR&D)

Glenmark Pharmaceuticals Ltd.

May 2008 - Feb 2010 (1 year 9 months)

Assist with sustained release (SR) tablet ANDA projects and conduct technology transfer batches for multiple ANDA products. Support development of a Para-IV delayed release capsule product up to pilot bioequivalence study stage.

Formulation Development ANDA Sustained Release (SR)Bioequivalence Para IV Delayed Release Capsules

Project Trainee (Trainee Scientist)

Glenmark Research Centre

Jun 2007 - Feb 2008 (8 months)

Develop MR capsule using extrusion-spheronization and diffusion coating technologies during a traineeship period. Support early-stage formulation work as part of the research centre activities.

MR Capsule Formulation

Education

Degrees, certifications, and relevant coursework

Govt. College of Pharmacy, Karad

Master of Pharmacy, Biopharmaceutics

2006 - 2008

Grade: First class

Master of Pharmacy in Biopharmaceutics (first class) from Govt. College of Pharmacy, Karad (Shivaji University, Kolhapur). Completed an academic project on multiparticulate modified-release formulation of verapamil hydrochloride at Glenmark Research Centre, Mahape, Navi-Mumbai.