Scientist/Chemist

SIRIPALA RANAWEERA, PhD

** ******* *****, **********, ** 08536

609-***-****; *******@*****.***

Highly talented, enthusiastic and innovative analytical chemist with extensive pharmaceutical R & D experience in method development (HPLC, GC, UPLC) for drug products (Solid/Parenteral), drug substance and quantitation of small molecular drugs in biological matrices (HPLC & LC/MS/MS), analytical method transfers, conducting “Out of Specification” investigations and management of outsourcing for contract research organizations(CROs). Comprehensive knowledge of GMPs and GLPs. Knowledgeable in ICH and FDA guidelines.

• Demonstrated innovativeness by introducing UPLC which is 10-20 times faster analytical technology than HPLC for drug release testing.

• Exceptional problem solving and troubleshooting skills. Remarkable ability to work in a multidisciplinary, fast-paced environment.

• Ability to meet project deadlines due to high organizational skills.

• Honored with company and other awards.

PROFESSIONAL EXPERIENCE

UNIVERSITY OF MEDICINE & DENTISTRY IN NEW JERSEY (UMDNJ)

Research & Teaching Specialist

Department of Molecular Genetics Microbiology and Immunology 2009 - present

Involved in protein purification research projects related to synthesis of proteins in yeast ribosome. Develop methods for the isolation and purification of elongation factors of protein synthesis, such as eEF2, eEF3 etc. Developed LC method for the purification of Pseudomonas aeruginosa exotoxin A – 24kDa C-terminal fragment using ion-exchange chromatography in AKTA LC system.

BRISTOL-MYERS SQUIBB CO., NEW BRUNSWICK, NJ 2001-2009

Senior Research Scientist - Department of Analytical Development 2003 – 2009

Evaluate, develop, validate and transfer analytical methods for solid/parenteral drug products and drug substance (API). Conduct Out of Specification investigations. Management of outsourced analytical work at contract research laboratories. Certification of reference standards. Preparation of compliance documentation. Management of laboratory staff.

• New Analytical Technologies: Convinced management to use an extremely fast (10-20 times) analytical technology “Ultra High Pressure Liquid Chromatography” (UPLC), as an alternative to conventional HPLC for release testing of drug products. Demonstrated how this new technology could be used to increase productivity through reducing drug release testing cycle time by 60%, analyst time by 50%, LC machine time by 50%, and the cost of solvent consumption and solvent disposal by about 80%. Honored with a spot award by the management for innovativeness, for proposing new ideas and timely completion of the project.

• Method Evaluation and Development:

• Evaluated analytical methods for robustness according to ICH and FDA guidelines and initiated improvements by developing new methods or making required changes, validated and transferred them to quality control laboratories.

• Developed potency, impurity and dissolution methods (HPLC, GC, UV/Vis, TLC, IR) for finished drug products and methods for cleaning verifications.

• Evaluated proposed compendial methods by United State Pharmacopeia (USP) and European Pharmacopeia (EP) for drug products, Cisplatin and Fosinopril- Hydrochlorothiazide and made recommendations for approval.

• Developed stability indicating HPLC method for the determination of BCNU and its impurity BCU in Carmustine for injection and submitted to USP Monograph, 2009 for publication.

• Prepared CMC documents for ANDA submissions

• Analytical Method Transfers: Performed Technological Transfers of Analytical Methods (Potency/CU, Impurities, Dissolution and cleaning verifications) to various BMS Quality Control laboratories and to third party manufacturers within United States, Italy, Brazil, Chile and Korea. Prepared analytical transfer protocols, reviewed data and wrote qualification reports.

• Out of Specification (OOS) investigations: Conducted Out of Specification (OOS) investigations at Quality Control laboratories and prepared investigative reports with recommendations. Identified the root cause of the out of specification analytical test result observed in a validation batch of a drug within three days of investigation which helped to resolve the issue and saved the tablet batch worth of millions of dollars.

• Managed Contract Research Laboratories (CROs) for outsourced analytical services: Partnered with Lancaster Laboratories and PPD laboratories to obtain analytical services for method validation including cleaning verifications. Prepared validation protocols, reviewed results and approved reports. Mentored analysts on cleaning verification techniques.

• Certification of Reference Standards: Managed analytical projects for the certification of reference standards to support the Reference Standards Group. Won a spot award for the completion of work on re-certification of a reference standard well ahead of the target date.

• Compliance Documentation: Participated in the departmental committee for the preparation of Standard Operating Procedures (SOPs) and Instrument Operating Procedures (IOPs).

• Management of Laboratory Staff: Trained and managed analysts in HPLC, GC and method validation including cleaning verifications.

Research Scientist - Department of Clinical Discovery & Analytical Science 2001 - 2003

Contributed to following bio-analytical projects related to PK clinical studies. These projects involved LC/MS/MS, HPLC method development and validation, use of SPE and automated biological sample preparation systems. Analyzed data and wrote reports.

• Developed and validated LC/MS/MS method for the quantitation of an anti-viral drug in human EDTA plasma using HLB 96-well SPE extraction in TECAN Genesis RS -150 automated system.

• Used On-line sample extraction system for quantitative determination of unchanged anticancer drug and its epimer metabolite in human EDTA plasma by LC/MS/MS.

• Developed and validated HPLC method for the quantitation of antifungal azole prodrug and the drug in human plasma using HLB 96-well SPE.

XENOBIOTIC LABORATORIES INC., PLAINSBORO, NJ 1999 - 2001

Scientist

Undertook Bioanalytical and Drug Metabolism Projects for outsourced customers such as: Pfizer, Bristol-Myers Squibb, and Novartis. Developed HPLC & LC/MS/MS methods for drugs in biological matrices. Designed experiments, prepared study protocols, conducted assays, analyzed samples and wrote analytical reports. Most of work conducted under GLPs.

• DMPK and ADME Studies: Conducted assays to evaluate (i) metabolic stability and metabolite profile of drugs in liver microsomes, hepatocytes and in S-9 fraction (ii) Drug inhibition of CYP450. Analyzed 3H and 14C radio-labeled test articles generated from ADME and pharmacokinetic studies.

• Drug Permeability: Conducted drug permeability studies using Caco-2 mono-layers. Drug permeability was evaluated by using HPLC and LC/MS/MS techniques.

• Bioanalytical: Developed HPLC and LC/MS/MS methods for the quantitation of small molecular drugs in biological samples (plasma, urine).

ANALYTICAL INSTRUMENTATION & DATA ACQUISITION SOFTWARE

HPLC Systems: Waters Alliance, Agilent HP

UPLC Systems: Waters “Acquity”, Thermo “Accella

GC Systems: Agilent HP

Mass spectrometers: PE Sciex 3000, Micromass Quattro/Ultima

Particle Size Analyisis: Malvern

Karl Fisher (KF) analysis

IR: Thermo Nexus FT-IR system

Automated Sample preparation: TECAN Genesis RS -150

Data Acquisition Software: Analyst, MassLynx, Millennium, Empower, Chemstation, LIMS-Watson 6

Protein Purification: Ion-exchange, Gel filtration, Affinity chromatography, SDS PAGE, Western blotting, ELISA. Use of AKTA LC system

EDUCATION

PhD - Analytical Chemistry, Friendship University, Moscow, Russian Federation

MS - Agricultural Chemistry, Friendship University, Moscow, Russian Federation

AWARDS

IAEA RESEARCH FELLOW - Department of Agricultural Biochemistry, University of Adelaide, Australia: Worked on “Involvement of cytochromes, C552 and C550 in electron donation for nitrate reductases for the reduction of nitrate to N2 in Rhizobium japonicum”.

VISITING PROFESSOR - Department of Life Sciences, Ben-Gurion University, Israel: Worked on “Characterization and partial restriction mapping of the largest plasmid (112kb) of Bacillus thuringiensis israelensis, which carries the genes responsible for its mosquito-larvicidal activity”.

PROFESSIONAL MEMBERSHIPS

Executive Committee - New Jersey ACS - Mass Spectrometry Discussion Group (2002 -2004)

Fellow - Institute of Chemistry, Sri Lanka (F.I.Chem, Sri Lanka)

IMMIGRATION STATUS: US Citizen

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