Satya Murthy Email & Phone Number

Foster City, CA, US

Provide strategic, managerial, and technical leadership to a team of internal team in a fully out-sourced environment as well as provide scientific input to scientists from CMOs as needed.

Foster City, CA, US

Responsible for global oversight and direction of analytical methods development and quality control activities related to the company’s new product development programs (e.g., NCEs, line extensions, in-license opportunities, etc.). Provide technical leadership and CMC expertise in support of the company’s due diligence and life cycle management.

Provide technical leadership and strategies in Formulation Development, Analytical Development, CMC, Quality control & CMOs/CLOs management. Provide technical and CMC expertise in support of the company’s due diligence, commercialization and life cycle management activities. Experienced in small molecules, peptides and proteins.Achieved modified release.

Basel, Baselstadt, CH

• Recruited by Novartis to start a newly created group focusing on External Development.
• Identified and qualified CMO’s to perform CMC development work and developed long-term and successful working relationships.
• Directed and managed a significant reformulation of a transdermal product at a CMO resulting in a successful IND filing. Resolved substantial formulation challenges that caused lower than expected release rates in a.
• Directed a group of formulation and analytical scientists at a CMO for the development of a nasal spray product for a proof of concept clinical study.
• Led a global cross functional CMC team for the development and European filing of an oral solid dosage product with successful outcome. Helped resolve and answer many CMC questions from member states during the review.
• In collaboration with a CMO, managed the development, clinical batch manufacturing and release of a combo tablet in tablet containing an enteric-coated tablet core for a proof of concept clinical study. Helped quickly.

US

• Joined Genta for a career opportunity and was responsible for all aspects of analytical development, validation and stability testing of sterile injectable oligonucleotide drug product at a contract laboratory. Managed.
• Directed the development and validation of a new HPLC ion-pairing method for the analysis of the oligonucleotide drug Genasense®. Performed studies to demonstrate the advantage of the new method for the separation of.
• Accomplished method transfer to a European contract laboratory
• Assisted in the review and approval of CMC sections of new drug applications with FDA and EMA and provided answers to review questions.
• Evaluated and qualified an alternate API supplier

Deerfield, Illinois, US

• Started as a Principal Scientist and advanced to a supervisory position in 2000.
• Directed and managed Analytical R&D laboratory consisting of eight analytical scientists supporting pre-formulation and formulation development work for injectable products. The analytical laboratory was responsible.
• Directed analytical research and development for a peptide drug. Provided analytical support for IND filing and manufacture of the clinical batch for Phase I studies. Characterized the impurity and degradation profile.
• Successfully led ANDA analytical development projects for three injectable drugs. All projects were accomplished on time and were approved without major deficiency. All projects involved method transfer to contract.
• Managed analytical and toxicological evaluation of “newly discovered” degradation products in an existing product to prevent potential recall of commercial batches. Led a multi-functional group consisting of R&D, DRA.

Principal Scienitst in Drug metabolism and Bioanalytical group

Research in Drug metabolism and Bioanalysis

Ph.D, Pharmaceutical Sciences

B.Pharm, Pharmacy