Dilip Ashtekar is a result oriented collaborative leader with over 39 years of successful proven record of handling increasing responsibilities in leading Pharmaceutical, Biotechnology, Cell therapy, and   Vaccine companies such as Intarcia Therapeutics, PAREXEL International, Gilead Sciences, Amgen Inc., AstraZeneca-MedImmune, Watson-Schein, Advance Tissue Sciences, Teva Pharma-Gensia Sicore, Chesapeake Biologics and CIBA‑GEIGY. Recognized as a proactive leader in anticipating, troubleshooting, resolving quality and regulatory issues, improving productivity and building high performance teams. 

An acknowledged industry expert in the following Areas

1. Microbiology, aseptic processing, contamination control programs, visible particle control for parenteral products and Devices, visual Inspection processes for parenteral drugs, compliance audits and building quality culture.

2. Data Integrity compliance and sterility assurance for the aseptic manufacturing of drug substance and sterile drug product (small molecules, therapeutic monoclonal antibody vaccines and proteins).

3.Extensive experience with sterile Medical Devices Combination Products.

4. Aseptic manufacturing facility validation conventional ISO5 cleanroom, Isolators and RABS.

A member of USP Council for Expert Microbiology Committee (2010-present) and serving as a key member of several PDA Task forces and key author Technical reports; Environmental Monitoring TR 13, Mycoplasma Clearance by Filtration and Rapid Microbiology Methods, TR 33) and Key expert of ISPE Microbiological Data Integrity Task force.