Prabo Wijetunge, Ph.D. Email & Phone Number

South Brunswick Township, Nj, Us

• Acts as a Pharma and Biotech Client Liaison and CMC expert.• Focuses on accelerating time-to-market and reducing tech transfer times through digitalization.• Provides cost- and time-saving solutions in CMC, analytical processes, combination products, lab services, scale-up, and manufacturing.• Collaborate with clients to respond to RFPs and develop comprehensive Statements of Work.• Identify and establish new profit centers, enhancing client offerings and expanding business opportunities.• Leverage predictive modeling, automation, and CMC digitalization to drive innovation and efficiency.• Oversee a $20M portfolio, managing five direct reports (program/project managers) to ensure projects are delivered on time and within budget.• Leverages Gen AI and Predictive AI for cost-effective solutions to produce synthesizable drug candidates.• Serves as a subject matter expert in pharma, biotech, and combination products.• Stays informed on industry trends, regulations, and best practices to offer valuable advice.• Collaborates with internal teams to align client needs with company capabilities.

• Successfully prepared plans to established a CMO/CDMO in a Southeast Asian country• Strategically set up the supply chain to establish Master Service Agreements with vendors• Led the establishment of manufacturing, QA, QC, and Regulatory processes

Princeton, New Jersey, Us

Somerset, Nj, Us

• Being the first employee of the inhalation department, established and lead the Generic and 505(b)2 Nasal, DPI product lines at Novel Laboratories.• Built the first inhalation development and testing lab at Novel laboratories and made the first Nasal Spray exhibit batches within 3 months of joining.• Pioneered and set up the “system and the procedures” for the generic inhalation drug development at Novel Laboratories. • Hire, train, manage and mentor a group of inhalation scientists (ARD/QC Process/Formulation Development).• Successfully prepared and submitted the first nasal Spray ANDA for Novel Laboratories to regulatory agencies.• Prepare CMC sections for ANDA submissions.• Lead the product development process with the Quality by Design (QbD) approach and make sure that the products adhere to the cGMP and regulatory guidelines. • Research and develop Brand, 505(b)2 and Generic Respiratory Drug Delivery products.• Research and buy new equipment, identify appropriate spray pumps, actuators, bottles, and manage the projects efficiently and effectively within budget and timelines. • Perform technical due diligence and gap analysis for the current and upcoming projects.• Develop risk mitigation plans with the support from the external vendors, key opinion leaders and external consultants. • Built and qualified three laboratories for respiratory product development (R&D/ QC testing and Process/Product Development). Develop protocols and perform IQ/OQ/PQ. Write SOP’s, Procedures, Batch Records, and Pharmaceutical Development Reports (PDR).• Collaborate with internal and external groups to complete the projects and file in a timely manner.• Responsible to search, select, tech transfer and manage CROs, CDMOs and CMOs for the inhalation product development.

Managerial Activities• Managed and lead the analytical methods development group.• Provided training and mentorship to the junior staffResearch and Development Activities• Successfully performed HPLC method developments, troubleshooting and verifications for APIs, drug substances and drug products• Effectively managed particle size measurement method development and validation activities at contract laboratories and facilitated the methods transfer (tech transfer) to cGMP manufacturing facilities• Developed and validated Aerosol Performance Testing Methods (Anderson Cascade Impactor: ACI, Next Generation Impactor: NGI and Dosage Unit Sampling Apparatus: DUSA)• Developed, verified and prepared reports on analytical methods for atropine sulfate inhalable drug product within time lines and within the budget• Designed experiments and managed a $1M new chemical entity (NCI) project very effectively within budget and time lines• Managed the solid state stability experiments of atropine sulfate at CROs and prepared reports • Developed and verified methods to determine moisture content in atropine sulfate and other drug products using Karl Fischer titrator• Effectively managed contract laboratories to fulfill the R & D requirements of MicroDose Therapeutx (MDTx)• Researched and brought in new technologies to improve capabilities of MDTx• Conducted stability studies for API and drug substances, prepared reports, address any deviations and improve stabilities.• Published and presented scientific findings at meeting and conferences.

Us

Danbury, Ct, Us

Developed and Implemented surface energy measurement techniques to aid in controlling aggregation of the Inhaled Insulin drug product. Developed projects to increase the shelf life of the finished drug product in order to increase the market acceptance. Developed, successfully completed experiments and written reports to support the New Drug Application (NDA). Investigated new peptides to deliver via inhalation. Formulated dry powder inhalable (DPI) drug products.

Columbus, Ohio, Us

Throughout five year career at Battelle, supported chemical and biochemical development and scale-up to cGMP Pilot Production. This has spanned GLP analytical and formulation; small and large molecules; individual contributions and supervision

Ph.D., Analytical Chemistry

B.Sc. (Hons.), Chemistry (Major), Physics (Minor)

G.C.E. (A/L), Mathematics

Education record