Saran Kumar Email & Phone Number

East Hanover, New Jersey, United States

East Hanover, Nj, Us

East Hanover, Nj

Pharmaceutical Development Unit (2008-Present)Leading and coordinating local and global teams. Initiating and influencing new scientific/development programs. Addressing complex R&D issues across line functions. Evaluating and implementing new innovative formulation and drug delivery technologies. • Strong leadership and partnership established with five technology partners that required extensive technical and contractual negotiations involving complex IP clauses. • Completed five phase I clinical trials for solid oral projects (2 internal & 3 partnered) through building alignment between GPT’s, line function and partners. Provided IMPD documentation for regulatory filings• Coordinated development of a unique solid dispersion formulation and established spray drying process with 2 partners for a poorly soluble, unstable drug.• Member of novel drug delivery technologies advisory board providing critical evaluations and decision making for feasibility studies and integration with Novartis portfolio.Director/Project Leader Lifecycle management & drug delivery technologies (2004-2008)Developed and implemented processes. LCM leader for oncology therapeutic area. Established LCM strategies for portfolio compounds. • LCM process, technology evaluation process and intellectual property process established and implemented with GPT’s. Instrumental in the development of technology platform organization with a matrix structure.• Drug delivery strategies for oncology portfolio established. Advisory panel conducted for targeted drug delivery and mitigation of food effect. Negotiated work plans, contracts and managed feasibility evaluations with partners.• Established LCM plans and novel formulation evaluations for several Novartis drugs including Tasigna, Glivec, Zometa, Exjade, etc.

Directed and positioned company’s supercritical fluid processing technologies for protein/peptide, DNA and small molecule applications for the biotechnology and pharmaceutical industries. Established a coherent scientific and technical strategy and an R&D infrastructure. Negotiated and established contracts. Directed and coordinated in-house and partner sponsored feasibility studies.

Nutley, Nj

Managed team of four Ph.D. level vice-directors. Leadership team managed the filing of Pegasys® and CoPegus® drugs with greater than billion dollar potential and the most visible project in the company at the time. • Coordinated CMC project management activities for the development, filing and launch involving six sites (two PEG reagent, two drug substance and, two drug product sites).• Coordinated the development, filing and launch of prefilled and needle-free delivery systems for Pegasys.• Additional responsibilities of the leadership team included management of the global supply chain and coordination of post marketing technical, regulatory requirements, life cycle planning and execution.

Ph.D, Industrial Pharmacy

B. Pharm (Hons), Pharmacy

B.Pharm (Hons), Pharmacy

M.Sc, Pharmaceutical Sciences