Dhananjay Pote

Experience

1. Manager Upstream Fermentation

   Lupin Ltd

   Oct 2015 — Present · Mumbai, IN

   Experience on development of Bacterial, Fungal and Actinomycetes Fermentations. Worked on production of Antibiotics, Anticholestrol, Oncological, Immunosuppressant products. Worked on laboratory, pilot and production plant as per GMP, GLP and various quality measures. Revival of cultures, Culture maintenance, Fermenter operations, Scale up activities. Technology Absorption and Transfer to next level. Qualification, Installation of Equipments. Laboratory validations. Production validation. Products handled: Rifamycin B, Mevilonoic Acid, A40926, Capreomycin, Daunorubicin, Cyclosporine, Hyaluronic acid, Daptomycin, Tacrolimus, Sirolimus, Mycophenolic acid, Citric Acid etc. Team leader, planning, administration. Trouble shooting in Production batches. Inputs in modification of process to R&D, Production and Engineering for Equipments. Batch data creation, maintenance and analysis at lab and Production scale with control chart. Training to the team members regarding any change, modification. SME for process, Deviation, Investigation and to set CAPA with QA and Engineering. Experiment design, and interpretation of the data. Supervise and review of the documents, LNB, Protocols and reports. Interaction with R&D, Fermentation, QA, QC, Engineering during developmental and day to day activities. Audits faced like USFDA, WHO Gennova, KFDA, Anvisa.

Education

• Yashwantrao Chavan College of Science, KARAD

  M. Sc., Microbiolgy

  2000 — 2002

• INDIAN SCHOOL OF BUSINESS MANAGEMENT AND ADMINISTRATION

  Master of Business Administration - MBA, Production and Operation Management, 1st

  2010 — 2012