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@lantheus.com
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Charles Van Kirk is listed as Director-Mfg. Analytical Development at Lantheus Medical Imaging, based in Beverly, Massachusetts, United States. AeroLeads shows a work email signal at lantheus.com, phone signal with area code 717, 978, 800, and a matched LinkedIn profile for Charles Van Kirk.
Charles Van Kirk previously worked as Director Of Manufacturing Analytical Development at Lantheus Medical Imaging and Associate Director Mfg. ANYL Development in Mfg. Technology (Ops) at Lantheus Medical Imaging. Charles Van Kirk holds Doctor Of Philosophy, Analytical Chemistry from University Of Delaware.
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Responsible for guiding the activities of analytical and process teams on small molecule and radiochemical products through the lifecycle from early (pre-Ph I) to full stage development (Ph IV) on the deliver of robust analytical methods including potency, low level impurity detection, and stability indicating techniques as well as exploration of parenterals. Provide expertise in the evaluation of candidates for QbD consideration and implementation.Goal:To provide technical expertise across various functions in order to further scientific understanding and enhance life by bringing new products to market.Specialties: Authoring CMC sections, Tech. Transfer, CMO management, parenteral & solid oral dosage forms, Stability, analytical chemistry, method & process validation, spectroscopy, electroanalytical chemistry, mechanistic determination, international exportation, US customs and USDA regulations, robot building and engineering, fine tool/dye machining,
Listed skills include Validation, Gmp, Analytical Chemistry, Technology Transfer, and 21 others.
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Bedford, Massachusetts, US
*Champion on the process and analytical qualification of contract manufacturing and testing organizations of parenteral, lyophilized, and gas products for worldwide distribution.*Lead author on CMC manufacturing, controls, container closure, validation, batch analysis, and stability sections for drug substances and drug products worldwide (including FDA.
Bedford, Massachusetts, US
Author and Champion of approved Ph.Eur. monograph for injectable productChampion of method development, validation and regulatory approval used on drug substances and drug products;Champion of aseptic manufacturing process technical transfer, commercial process validation, site qualification, and manufacturing controls;Lead author of CMC dossiers and.
Boston, MA, US
Provide and manage the Analytical strategy, planning and support on newly emerging and line extension programs. Implement QbD processes and oversee use of HPLC, GC, dissolution and PAT method development, validation & transfer to CRO & CMOs in accordance with cGMP regulations.
Boston, MA, US
Analytical support to lifecycle management,Implement QbD processes and oversee use of PAT Develop,validate & transfer to CRO/CMOs HPLC/Disso/GC/KF methods
Lawrence Township, NJ, US
Implementation of novel process analytical technology (PAT) into the API and drug product. PLUS work on the scale-up and technical transfer of drug product processes from LTSS through process validation into product launch.
This work was concentrated on HPLC/UV/Fluorescence method development and validation (based on USP protocols) for drug products from phase I to commercial release. Additional work was on the completion of reports for FDA filings (iNDA, sNDA) and drafting of departmental SOPs and operating instructions.
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Charles Van Kirk works for Lantheus Medical Imaging.
Charles Van Kirk is listed as Director-Mfg. Analytical Development at Lantheus Medical Imaging.
AeroLeads has found 1 work email signal at @lantheus.com for Charles Van Kirk at Lantheus Medical Imaging.
AeroLeads has found 3 phone signal(s) with area code 717, 978, 800 for Charles Van Kirk at Lantheus Medical Imaging.
Charles Van Kirk is based in Beverly, Massachusetts, United States while working with Lantheus Medical Imaging.
Charles Van Kirk has worked for Lantheus Medical Imaging, Vertex Pharmaceuticals, Bristol-Myers Squibb, and Rhone Poulenc Rorer.
You can use AeroLeads to view verified contact signals for Charles Van Kirk at Lantheus Medical Imaging, including work email, phone, and LinkedIn data when available.
Charles Van Kirk holds Doctor Of Philosophy, Analytical Chemistry from University Of Delaware.
Charles Van Kirk is listed with skills including Validation, Gmp, Analytical Chemistry, Technology Transfer, Chemistry, Fda, Sop, and Quality By Design.
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