Summary
Work History
Education
Skills
Accomplishments
Affiliations
Timeline
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SATEESH KUMAR PINNINTI

Head, Process Development
Hyderabad,TG

Summary

Strategic and accomplished Research Scientist Head with extensive expertise across the pharmaceutical lifecycle — from drug discovery to commercial drug development. Skilled in leading CRO/CDMO collaborations, managing technology transfer, and driving process development initiatives that enhance efficiency and compliance. Experienced in handling regulatory submissions and responses to regulatory queries, ensuring smooth approvals and market readiness. Recognized for leadership in mentoring scientists, bridging academic excellence with industrial execution, and delivering measurable improvements in pharmaceutical manufacturing.

Work History

Senior General Manager & Head of Process Development

Apitoria Pharma Ltd.
  • - Directed drug discovery and development programs, integrating CRO/CDMO partnerships for efficiency and compliance
  • - Led technology transfer of multiple drug substances, ensuring robust scale-up and regulatory alignment
  • - Spearheaded process development initiatives, achieving measurable RMC and overhead reductions
  • - Strengthened process development team capabilities, mentoring scientists to improve troubleshooting and process robustness
  • - Oversaw drug development lifecycle, from early-stage synthesis to commercial manufacturing
  • - Coordinated with regulatory agencies, preparing submissions and drafting responses to regulatory queries, ensuring smooth approvals

Education

PhD - Organic Chemistry (Anticancer Drug Synthesis)

GITAM University

MSc & BSc - Chemistry

Andhra University

Skills

- Drug Discovery – anticancer drug synthesis, novel therapeutic identification

- CRO/CDMO Partnerships – managing outsourced research and manufacturing collaborations

- Technology Transfer – seamless scale-up from lab to commercial production

- Process Development – optimization, impurity profiling, and cost reduction

- Drug Development – end-to-end lifecycle management from preclinical to commercial stage

- Regulatory Handling – submissions, compliance, and responding to agency queries

- Leadership & Mentoring – building high-performing teams and fostering scientific excellence

Accomplishments

  • - Implemented several cost improvement project with respect to the rest of the world as well as US, EP and JP.
  • - Established strong CRO/CDMO networks, accelerating timelines for drug development projects
  • - Successfully managed regulatory submissions and responses, supporting approvals in multiple markets
  • - Published and presented research on drug synthesis and process optimization
  • - Recognized for mentorship and leadership, bridging academic knowledge with industrial practice.

Affiliations

● Instant Recognition Award for best performance in 2009

● Recognition of outstanding contribution towards safety at the Hyderabad Research Centre and notable accomplishment and beyond scope of responsibility reorganization award, Nov 2010.

● Best process development project -2023, 2024 & 2025 from Apitoria.

Timeline

MSc & BSc - Chemistry

Andhra University

Senior General Manager & Head of Process Development

Apitoria Pharma Ltd.

PhD - Organic Chemistry (Anticancer Drug Synthesis)

GITAM University

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SATEESH KUMAR PINNINTIHead, Process Development