Product Development R D

OBJECTIVE:

To continue successful Research & Development Formulation practice in Generic (Rx & OTC) with exceptional hands-on experience from Concept to Completion, where my qualification and experience can enhance organizational operational development, profit growth, mission objectives, efficiency, resource utilization and employee satisfaction.

AREA OF EXPERTISE:

Pharmaceutical formulation technology professional with Comprehensive Rx & OTC Generic background in Product Development and Process Development as per QbD.

■ R&D Management (Formulation, Execution & Analytical data interpretation) ■ Scale-up ■ ANDAs’ Manufacturing ■ Support CMC Regulatory & Compliance ■ Multi-site Tech Transfer ■ Process Improvement ■ Team Leadership & Training ■ New Product Development ■ Implementation of Technologically Innovative Approach.

■ Formulation Product & Process development followed by successful Tech transfer practice based on the guidelines of ICH, US-FDA & WHO in generic drug development with exceptional hands-on experience from Concept to Completion.

CAREER SUMMARY:

FORMULATION & TECH TRANSFER SCIENTIST with technically sophisticated and Seasoned High-profile career spanning 29+ years enhancing growth and profitability in R&D arenas.

WORK EXPERIENCE

New York, U.S.A Chapter

ABON PHARMACEUTICALS LLC, 100 CHESTNUT RIDGE, NY 10977. USA MARCH 2021 TO PRESENT

SCIENTIST, FORMULATION R&D

Responsible for the Formulation development R&D. Define Product Development Strategy. Reference product info (RLD). API characterization. Raw material sourcing. Making Quality Target Product Profile (QTPP). Defining CQA’s & CPP’s. Doing DOE’s. Formulation & Product Development Strategy at Lab Scale. Stability Protocol preparation & Execution. Equipment & Machineries. Packaging Development. Process Optimization at Pilot Lab scale. BE study.

Preparing documents including Tech Pack, Interim Development report, Protocols, Weekly Development plans as well as presentations. Preparing PDR (3.2. P.2 CTD format).

Actively Participated in technical meetings with Analytical Lab, Material Management, Marketing & Regulatory dept. Evaluating analytical results as per USP & FDA guideline.

Active member to hold Formulation & Tech Transfer Meeting.

Also worked as Tech Transfer Head (DBL Pharmaceuticals Inc. USA) with Cerovene Inc, NY to facilitate Tech Transfer of IR & MR Oral Solid products from Cerovene USA (R&D site) to RA Chem Pharma (CMO) in India for DBL Pharma USA.

Dubai, U.A.E Chapter

Product & Process Development Officer in PHARMACARE, FZE (Life Pharma now) from 2004 to 2006. Formulation and process optimization.

Scale-up to commercial batches, with control over packaging materials and production specifications by ensuring compliance with FDA & MHRA requirements and relevant regulations.

Created detailed protocols for formulation and process development by aggressively pursued opportunities to control and reduce process costs without compromising quality.

Production Supervisor (Shit In-Charge OSD) in Gulf Pharmaceuticals (JULPHAR) from 1994 to 1998. Performed the Shift in-Charge duties for manufacturing a variety of pharmaceutical dosage forms including tablets, capsules, sugar coated and film coated tablets, delayed release enteric coated tablets, PPS (Pre-Powder Suspension) etc.

Worked as active Team member in Internal Tech Transfer of Solid products from R&D to Production.

Bangladesh Chapter

General Manager, Product Development in DBL Pharmaceuticals from 2017 to 2019. Manage and direct the research and development programs to meet organizational needs and to capitalize on potential new products.

Develop and implement research and development procedures and techniques and play dual design function roles.

Ensure all developing projects, initiatives, and processes are in conformance with organization's established policies and objectives.

Responsible for the direct management of complex R&D projects involving a team of scientific staff. Programs managed represent large high growth potential breakthrough or platform scale development opportunities.

Worked as Site Tech Transfer Head in collaboration with Cerovene inc, USA & RA Chem Pharma, India.

Senior Manager, Product Development in Square Pharmaceuticals from 2006 to 2016. Responsible for the direct management of whole R&D projects involving a team of scientific staff.

As a head formulator successfully organized, provided leadership, coordinated and directed the project team on high visibility product development programs.

Maintained Square's competitive position and profitability in Bangladesh by formulating research and development programs. Familiar with a variety of the field's concepts, practices, and procedures.

Conducting regular Meeting with Marketing & Technical Services department to accelerate the Product development timeline.

Assistant Manager, Product Development in RENATA LIMITED (ex Pfizer Bangladesh) from 1999 to 2003. Reports to Plant Manager, performed overall responsibilities of R&D from Formulation to product launch.

Production Supervisor in ESKAYEF BANGLADESH LIMITED (ex SK&F Bangladesh) from 1994 to 1998. In-Charge of Liquid preparation & Packaging Supervision of all the Dosage Forms.

EDUCATIONAL QUALIFICATION

MS in Industrial Pharmacy

University of Dhaka, Bangladesh, Jan’1992

Bachelor of Pharmacy

University of Dhaka, Bangladesh, Jan’1990

Reference:

Dr. Mohammad Zafar Iqbal, Vice President, R&D

Glatt Air Science, Ramsey, NJ 07446.

Cell: 845-***-****

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