Masihuddin Jaigirdar by profession a Pharmaceutical Scientist, before retiring he was the senior Quality Reviewer, US Federal Government (G.S-14-8) with FDA/OPQ/OPMA Division III. Beside his quality reviews of many applications including INDs, NDAs and over 500 ANDAs/Amendments for a period of over ten years; he has also contributed/participated in FDA OGD/OPMA various scientific working groups as a team member. In October 2020 for his dedication to the FDA through his 10 years of exemplary service as an exceptional employee and mentor, received the certificate of appreciation from the CDER; FDA.
He has M. Pharm and Post Graduate Education in Pharmaceutical Science/Technology and over 35 years of diverse experience in the Pharmaceutical Industry in the field of Formulation Development, Process Technology Transfer, Process Optimization, and Scale-up of products and Manufacturing for Brand and Generic Pharmaceuticals in US and Overseas (Europe & Middle East).
As a formulation scientist he has proven success of generating many Abbreviated New Drug Applications (ANDAs) of Paragraph IV Paradigm defending them at litigation and got agency approval. He has worked for many worlds reputed Pharmaceutical Companies.
He was the Associate Director and Research Leader of R&D Product Development; expertise in Modified Release Technology for Actavis (former Watson) Pharmaceuticals in Corona, California.
Masih was Senior Principal Scientist, for the generic division of Marion Merrill Dow (MMD), Hoechst Marion & Russel, Aventis; (Chelsea Laboratories), in Cincinnati, Ohio.
Just before joining FDA in September 2010, he was with the Product Development Group of Mylan, in Morgan Town, West Virginia.
Masih started his professional career in early 70’s, joining the then E.R.Squibb & Sons in their overseas pharmaceutical plant in Bangladesh. In the 80’s was trained by ASTRA Development AB, Sodertalje, Sweden, for the position of Head of Process Technique/Technology Transfer, for the newly build pharmaceutical plant KIPICO of the Kuwait (Middle East) government. He was responsible and conducted the Validation Program for Product’s Process: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) in conjunction with technical experts from ASTRA Sweden for all pharmaceutical dosage forms.
Provided technical support and troubleshooting to existing products and process.
Has written and revised production methods, batch production records, SOPs and validation protocols.
Field of Knowledge/Experience/Exposure/Expertise
Solid Oral Dosage: Immediate Release, Modified Release (Controlled Release & Delayed Release)
Semi Solids: Ointment, Cream, Gel and Suppositories Technologies
Liquids: Internal-Liquid (Oral Solution, Suspension, Elixirs, and Emulsion); Injectable: SVP & LVP, Peritoneal Dialysis and Hemodialysis solutions, ophthalmic preparations and Nasal Spray etc.
Awards: Masih has received many awards during his 10 years’ service with the FDA.
• Certificate of Appreciation for dedication to the FDA through his 10 years of exemplary service as an exceptional employee and mentor, October 13, 2020.
• Award received (group): In Recognition of the OPF Training and Development Team sponsoring cross-OPQ training and development activities, December 13, 2016.
• Leadership Excellence; OPF Continual Learning Committee, September 16, 2016.
• Certificate of Appreciation: Risk Based Review Pilot Program, February 10, 2014
• Excellence in Mentoring: Training Faculty for New Chemist Reviewers; For outstanding efforts in training over 65 new chemists in the review of Chemistry, Manufacturing, and Control portion of the ANDA in 2013
• OGD Chemistry Risk-Based Review Groups; for demonstrating the feasibility, effectiveness and efficiency of risk-based review in the chemistry evaluation of ANDAs
• Speaker at OPF Knowledge Sharing Seminar Series.
• CDER Office of Generic Drugs, Certificate of Appreciation; “Role of Scale-up Strategy in Product Development and Formulation, March 14, 2011.