Deepak Mundhra
Lafayette Hill,PA
Summary
20 years of experience in drug product formulation development including process development, scale-up and manufacture of clinical supplies. Experienced in development and scale-up of injectable, oral solution and oral solid dosage forms for small molecules. Experienced in authoring pharmaceutical development modules of IND, IMPD, NDA, MAA. Develop phase-appropriate project plans with CDMOs, participate in CDMO selection and engage with CDMOs for development and manufacture of clinical supplies.
Overview
21
21
years of professional experience
Work History
Senior Director, Drug Product Manufacturing
Athira Pharma, Inc.
07.2022 - Current
- Responsible for all drug product activities at Athira Pharma which included a portfolio of Fosgonimeton subcutaneous injection in pre-filled syringe (PFS) for Alzheimer's disease and ATH-1105 for treatment of ALS.
- Conceptualization and formulation development of Fosgonimeton subcutaneous injection at multiple global CDMOs. Scale-up and successful tech transfer to 100 L batch size. Formulation (composition of matter) patent filed in Sep 2024 as the sole inventor.
Scientific Leader, Pharmaceutical Development
GSK
04.2017 - 04.2022
- Led the conceptualization, formulation development, scale-up, technical transfer and commercial launch of Cabotegravir Injectable Suspension in CABENUVA, the first long acting injectable for the treatment of HIV from pre-clinical discovery stage over a period of 12 years.
- Led the conceptualization and formulation development of Cabotegravir Injectable Suspension in CABENUVA for self-administration using an autoinjector.
- Resolved multiple issues related to needle clogging in pre-filled syringe, re-suspendibility of drug product and syringeability challenges upon long term storage.
Investigator, Formulation Development
GSK
06.2006 - 04.2017
- Responsible for all aspects of drug product development including formulation, manufacturing process and scale-up for sterile milling and terminal sterilization of multiple long acting injectable drug products. Formulation (composition of matter) Patent# 11,224,597 B2 issued on 18 Jan 2022.
- Extensive experience in working in matrix teams of drug substance, analytical development and manufacturing technical transfer team.
Formulation Scientist
Ohm Laboratories, Inc
10.2004 - 05.2006
- Develop robust and stable formulations in compliance with cGMP for ANDA filings for tablets, capsules and oral liquid dosage forms. Operate a range of processing equipments including granulators, blenders, tablet press, encapsulators and coaters. Conduct scale up and transfer formulation technology from lab-scale to production.
Research Associate
McNeil Consumer & Specialty Pharmaceuticals, Inc
08.2003 - 09.2004
- Formulation development of Infants’ Tylenol Concentrated Drops and Children’s Tylenol Suspension. Design of experiments to screen the use of various excipients that could help prevent the discoloration of the dye-free Tylenol formulations.
Education
Master of Science in Industrial Pharmacy - Industrial Pharmacy
St. John’s University
Jamaica, NY05.2003
Bachelor of Pharmacy - Pharmacy
University of Mumbai
Mumbai, India06.2000
Timeline
Senior Director, Drug Product Manufacturing
Athira Pharma, Inc.
07.2022 - Current
Scientific Leader, Pharmaceutical Development
GSK
04.2017 - 04.2022
Investigator, Formulation Development
GSK
06.2006 - 04.2017
Formulation Scientist
Ohm Laboratories, Inc
10.2004 - 05.2006
Research Associate
McNeil Consumer & Specialty Pharmaceuticals, Inc
08.2003 - 09.2004
Master of Science in Industrial Pharmacy - Industrial Pharmacy
St. John’s University
Bachelor of Pharmacy - Pharmacy
University of Mumbai
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