Nilantha Sirisoma
API Process R&D, Drug Substance Manufacturing, Small Molecules, Drug Design and Discovery, Route Scouting, Tech Transfer, CRO/CDMO Management, GMP, GLP/Tox, Phase 1&2, Regulatory IND
- Role
- Associate Director, Chemical Development at Acadia Pharmaceuticals
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Nilantha Sirisoma
Process development and drug substance manufacturing leader with over 15 years in the biotechnology and pharmaceutical industries. Career Highlights:• Research projects in biotechnology resulted in FDA approved drug Zurampic (Lesinurad) for treatment of Gout and Phase 2 trial for treatment of cancer (Azixa)• Co-inventor of 8 issued U.S. patents and 13 published international patent applications, 23 published research papers as well as 21 presentations in national and international meetings• Excellent practical and theoretical knowledge of medicinal, synthetic and parallel chemistry• Compelling team player, deliver ideas, develop collaborative plans with enthusiasm and foster individual ownership • Commitment and Passion to achieve goals both technical and non-technical• Ability to work in a dynamic, fast-paced, timeline-based environmentSpecialties:• Practical experience with intermediate and API scale-up under cGMP for Phase 1 and 2. • Author CMC sections for regulatory submissions (IND and IMPD). • Tech transfer to potential partners. •Provide Person in Plant (PIP) support for manufacturing/process development runs at CMOs as needed. • Manage all aspects of outsourced development programs, vender selection, oversee CMO/ CRO/CDMO activities • Writing and reviewing Batch Manufacturing Records (BMR), Standard Operating Procedures (SOP), Development Reports, quality standards, protocols, and release documentation. • RFP contract negotiations and budgeting for drug substance and drug product manufacture, testing and release. • Integrate well with cross-functional teams • Ability to effectively manage multiple priorities through strong organization and time management skills.
Experience
Associate Director, Chemical Development
Jun 2025 — Present · San Diego, CA, US
Responsible for the chemical process development, implementation and management of robust, cost-effective, and safe processes for the manufacture of APIs from the research stage, through clinical development and marketing approval.
Education
Wesleyan University
M.Sc.
1989 — 1991
University of Colombo
B.Sc., Chemistry
1982 — 1986
University of California, Berkeley
Postdoctoral Research Fellow
1999 — 2001
Wayne State University
Ph.D., Organic Chemistry
1992 — 1997
Skills
- Synthetic Organic Chemistry
- Gmp
- Cancer
- Pharmaceutical Industry
- Sop
- Nmr
- Validation
- Medicinal Chemistry
- Heterocyclic Chemistry
- Biotechnology
- Organic Chemistry
- Process Development Chemistry
- Technology Transfer
- Chemistry
- Parallel Synthesis
- Hplc
- Life Sciences
- Drug Discovery
- Ir
- Drug Design
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