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Experienced Senior Director of Product Management with a demonstrated history of working in the pharmaceuticals industry. Skilled in Biotechnology, U.S. Food and Drug Administration (FDA), Life Sciences, CRO Management, and Technology Transfer. Strong operations professional with a Doctor of Philosophy (Ph.D.) focused in Pharmaceutics and Industrial Pharmacy from LIU.
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Executive Director Of Drug Product ManufacturingChimerix, Inc. Dec 2024 - PresentDurham, Nc, Us -
Senior Director, Drug Product ManufacturingChimerix, Inc. Jan 2019 - PresentDurham, Nc, UsPharmaceutical Executive with extensive experience in the Pharmaceutical industry in the USA focusing on development of drug product development and commercial manufacturing. Involved in the product development from basic research through manufacturing scale up, GMP documentation, clinical trials, regulatory affairs and technical writing. Evaluation of new investments, and technological break-through and opportunities. Significant contributions and strengths include:• Guiding, training and directing R&D team of scientists in every aspect to development including data interpretation.• Hand on formulation developments and manufacturing experiences for supporting the BARDA programs.• Collaborating with third party vendors to manage/ guide the outsourced activities and provide both interim and final deliverables within reasonable time and budget constraints.• Extensive knowledge of solid, semisolid, liquid, nasal spray and sterile IV/IM/SC dosage forms development.• Extensive experience with controlled release dosage forms including controlled release liquid product as well as IM formulations.
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Director, Drug Product ManufacturingChimerix, Inc. Jun 2015 - Dec 2018Durham, Nc, UsManaging research, developments and Manufacturing as related to formulation and manufacturing process development of new compounds/ technologies, existing Chimerix compounds/formulations. Dosage forms include oral liquids, oral powders, oral tablets and sterile IV formulations. Responsibilities included pre-formulation, formulation, tech transfer, scale-up, and process optimization based on QbD principals, validation, manufacture, including product transfer to commercial manufacturer sites and trouble-shooting for all Chemirix drug products, starting at tox study and Phase I through commercialization. Hand on formulation developments and manufacturing experiences to support the BARDA programs through CLIN1 – CLIN 4.Served as the lead in a complex manufacturing process for a safe bridge class IV compound for lyophilized IV formulation as well as other oral formulations, including tablets, suspension and powder for oral suspension.Worked with Legal, Supply Chain, and Manufacturing to lead contract negotiations with outsourcing partners for development/manufacturing agreementsServe as the lead in formulation developments and manufacturing experiences to support the BARDA programs through CLIN1 – CLIN 4.Develop oral suspension and powder for oral suspension formulations, supply clinical materials, perform process characteristic using elements of QbD principal DoE studies (JMP-12) and validate the commercial suspension Sterile or aseptic process in IV product formulation and manufacture, including Lyophilization IV formulation development, critical process parameters identification and Lyophilization cycle development.Served as an author of CMC documents of Chimerix first NDA for FDA approval.Served as the primary contact and managed multiple vendors for IV/IM, oral suspension and tablets drug product.
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Director Formulation DevelopmentSalix Pharmaceuticals Apr 2009 - Jun 2015Bridgewater, N.J, Us4 April 2009 -
Senior Principal ScientistSchering-Plough Pharmaceuticals May 2005 - Apr 2009Rahway, New Jersey, Us -
Preincipal ScientistPerrigo Company Plc Mar 2003 - May 2005Dublin, County Dublin, Ie -
Sr ScientistPerrigo Company Plc 2003 - 2005Dublin, County Dublin, Ie
Mohammed Kabir Skills
Mohammed Kabir Education Details
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LiuPharmaceutics And Industrial Pharmacy
Frequently Asked Questions about Mohammed Kabir
What company does Mohammed Kabir work for?
Mohammed Kabir works for Chimerix, Inc.
What is Mohammed Kabir's role at the current company?
Mohammed Kabir's current role is Executive Director at Chimerix, Inc..
What is Mohammed Kabir's email address?
Mohammed Kabir's email address is mo****@****lix.com
What is Mohammed Kabir's direct phone number?
Mohammed Kabir's direct phone number is +191980*****
What schools did Mohammed Kabir attend?
Mohammed Kabir attended Liu.
What skills is Mohammed Kabir known for?
Mohammed Kabir has skills like Pharmaceutical Industry, Formulation, Gmp, Biotechnology, Chemistry, Regulatory Affairs, Drug Development, Cro, Fda, Sop, Technology Transfer, Clinical Trials.
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