Rafiqul Islam
Product Development Manager @Elite Pharmaceuticals, Inc
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WORK HISTORY
Product Development Manager @Elite Pharmaceuticals, Inc
Northvale, NJ, US
Spearhead product development for oral solid dosage (OSD) drug products, overseeing technology transfer initiatives.• Engage in due diligence to assess process compatibility, plan tech transfers, set specifications, and conduct risk assessments.• Collaborate closely with API teams and supply chain to ensure effective manufacturing processes.• Conduct comprehensive risk assessments to identify and mitigate potential issues, maintaining detailed product risk registers.• Ensure compliance with Quality by Design (QbD) principles by defining key process parameters and establishing monitoring systems.• Track drug product performance amid material and process changes, implementing change controls post-PPQ completion.• Provide technical directions on manufacturing processes, aiding investigations and troubleshooting efforts.• Supervise analytical development activities to facilitate product characterization, testing, and reporting.• Prepare batch records, protocols, and data summaries to support ANDA filings.• Facilitate clinical studies and stability assessments, driving the development team to reach project objectives.
EDUCATION
University of Dhaka
B. Pharm.
NAGASAKI UNIVERSITY, Nagasaki, Japan
Ph.D.
UNIVERSITY OF IOWA, Iowa City, Iowa
Post-Doctoral Research Scholar
University of Dhaka
M.Pharm., Pharmaceutical Technology
ABOUT RAFIQUL ISLAM
PROFESSIONAL SUMMARYInnovative Formulation Scientist with extensive experience in developing oral solid and liquid dosage forms. Expertise in research and development, statistical analysis, and DOE. Proficient in report generation, process development, scale-up, and technology transfer leading to successful ANDA filings and approvals. Strong foundation in regulatory compliance, adhering to GMP, FDA, EU, and Health Canada standards. Skilled in formulating complex pharmaceutical dosage forms, including prescription and over-the-counter products, with a specialization in immediate and modified-release formulations, fast-dissolving tablets, capsules, solutions, suspensions, nasal sprays and sterile products. Exceptional project management abilities, effectively organizing logistics to ensure timely completion of development initiatives while managing multiple projects concurrently.CORE COMPETENCES•ANDA Development: Proficient in developing diverse dosage forms, overseeing projects from initiation to successful ANDA filings, approvals, product launches, and commercial manufacturing.•Regulatory Submission: Skilled in preparing critical regulatory documents, including the QOS (Module 2) and PDR (Module 3), contributing to comprehensive CMC filings.•Documentation and Compliance: Developed and reviewed essential documentation, ensuring compliance and supporting successful product launches.•Pharmaceutical Technology: Expertise in advanced oral solid dosage technologies, including granulation, palletization, tableting, and coating.•Mentorship and Leadership: Supervised junior scientists and technicians, fostering professional development in pharmaceutical technologies.•Project Management: Managed multiple product development projects, implementing innovative technologies to enhance productivity and efficiency.•Collaboration: Effective communication and interpersonal skills to collaborate with cross-functional teams.•Research and Analysis: Conducted literature and patent evaluations, sample characterization, and excipient compatibility studies to optimize manufacturing processes.•DEA Compliance: Managed DEA tracking and ensured compliance with regulations for controlled APIs.INDUSTRY ACHIEVEMENTS/SKILLS•Developed and managed technology transfer for Rx and OTC products, successfully launching multiple formulations within project timelines.•Contributed to the approval of nine Abbreviated New Drug Applications and facilitated four additional submissions currently in progress.•Statistical Software: Minitab 17, S-Matrix•MS Office•Adobe Photoshop
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