Mark Kleinman Email & Phone Number

Melbourne, Victoria, AU

• Led team of project leaders/managers developing medicines for hematology indications including hemophilia, acute bleeding, sickle cell disease derived from plasma, recombinant proteins as well as gene therapy
• Achieved the successful, on time integration of a biopharmaceutical company into CSL Behring
• Provided leadership, managed and helped to develop US launch plan for a novel gene therapy asset (HEMGENIX, winner of a Prix Galien) for hemophilia B from Phase 3 through submission of the MAA and BLA
• Sponsored redevelopment of project management planning and reporting tool to enhance project planning and improve data quality
• Managed or was member of multiple due diligence teams
• Panelist or Lead facilitator at WHY Summits PPM Conferences

Brentford, Middlesex, GB

*As PPM Point of Accountability for Dermatology and member of the Dermatology TA Leadership Team, interacted with TA Heads and senior leaders from CMC, clinical, finance, portfolio to help grow the business and develop integrated, global investment and project strategies. *Designed, developed and implemented a TA governance process which enabled faster and.

Brentford, Middlesex, GB

Responsible for the research & development budget, strategic planning, scheduling and execution for multiple small molecule medicine development projects in infectious diseases, cardiovascular and dermatological (Stiefel, a GSK company) therapy areas.

Brentford, Middlesex, GB

• Responsible for ensuring all analytical (methods, specifications, in-process analytical testing and safety and clinical release testing) timelines and objectives are met for pre-candidate selection to Phase II NCE.
• Led investigations of stability and identification of unknown impurities and degradation products in API and drug product

Brentford, Middlesex, GB

Physical Properties & Developability – Pharmaceutical Development- Led investigations of stability and identification of unknown impurities and degradation products in API and drug product under biorelevant and stressed conditions- Helped formulate GSK strategy on potentially genotoxic impurities

Brentford, Middlesex, GB

Physical Properties & Developability - Pharmaceutical Development- Started up and led team to investigate stability of drugs under biorelevant and stressed conditions- Designed, conducted and interpreted physico-chemical characterization of drug substance and drug product

Brentford, Middlesex, GB

Developability, New Chemical Entities, Pharmaceutical Development- Designed, conducted and interpreted physico-chemical characterization of drug substance and drug product- Characterized formulation stability

New York, NY, US

- Developed methods to study adsorption and mobility of PAH’s, PCB’s and CFC’s on catalyst and soil surfaces by spectroscopic and chromatographic (GC, HPLC) techniques- Evaluated the thermal and photochemical degradation of PAHs, diaryldiazo compounds and CFC’s on aluminosilicates by GC-MS, GC-FID/ECD and EPR- Examined the inclusion of acidity probes in.

Certificates

Ph.D., Physical Organic Chemistry

Bsc, Biochemistry