Upendra Kulkarni, Ph.D. Email & Phone Number

Cambridge, Ma, Us

Basel, Baselstadt, Ch

Chemical and Pharmaceutical Profiling• Lead the early formulation efforts for preclinical projects in the discovery teams and utilize the late stage development expertise to act as a liaison for transition of injectable drugs from discovery to development• Lead efforts focused on developability assessment, physical form screening and selection, and formulating early stage small molecules and then advancing them into early clinical development.

Thousand Oaks, Ca, Us

1. Commercial Process Development of small molecule and biologics. 2. Design, development and characterization of manufacturing process for commercial sites. 3. Scale-up of formulation fill finish processes for commercial operations. 4. Technology transfer to global commercial sites - internal Amgen manufacturing sites and CMOs worldwide. 5. Lyophilization process development and robustness studies for commercial scale. 6. Characterization of lyophilizers at lab, pilot and commercial scale for successful transfer of product temperature profiles - determination of heat transfer coefficient, cake resistance, and lyo process modeling.7. Authoring of CMC sections of NDA, BLA and Biosimilar regulatory filings in US and EU for product launch and commercialization.

Basel, Baselstadt, Ch

• Plan and execute the formulation development activities of parenteral formulations of NCEs from preclinical to Phase 3 clinical stage• Conduct scale-up and technology transfer of parenteral formulations at Novartis internal plants and external CMOs• Prepare high quality CMC documentation associated with the formulation development activities• Provide project deliverable to global teams on time, meet quality metrics in project execution• Clear, correct, and timely communication of project activities to global colleagues and global sub-teams• Actively contribute to Formulation labs build up and set up in Hyderabad, India (procurement and qualification of instruments from global sites, laboratory setup, establish procedures and guidelines for formulation processes and equipments)• Supervise and impart training, assign project activities and perform appraisal of formulation associates

Bangalore, Karnataka, In

• Design and conduct preformulation studies and formulation development of peptides/proteins • Design and conduct stability programs to support various phases of product development (pre-clinical to phase III clinical studies) • Conduct process development and scale-up from preclinical to commercial scale manufacturing • Execute technology transfer of multiple formulations to partners and CMOs worldwide• Provide support to manufacturing, clinical and regulatory groups of the CMC team

• Lead scientist role in the preformulation and formulation development of parenteral drug products • Provided technical support for manufacture of CTM batches of lyophilized drug product• Prepared technical documents like Manufacturing batch records, Filling batch records and CMC section of IND document for GMP manufacture of a parenteral drug product• Provided key input in the nomination of NCEs and determined their preformulation characteristics and developed various formulation strategies• Conducted preformulation studies and developed formulations for pre-clinical and clinical supplies• Determined polymorphism, hygroscopicity and flow properties of various small molecules using DSC, TGA and DVS instruments• Determined glass transition and collapse temperature using DSC and freeze drying microscopy for small molecules• Represented formulation group in Discovery, PharmaDev and regulatory CMC meetings• Conducted drug substance and formulation stability studies and analyzed them using HPLC• Supervised temporary research associate and summer intern on multiple projects and provided training on various preformulation and formulation activities

Ph.D., Pharmaceutical And Chemical Sciences

B.Pharm., Pharmaceutical Sciences