Charles Kirk
Associate Director Mfg. ANYL Development in Mfg. Technology (Ops) at Lantheus | North Billerica, Massachusetts, United States
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Charles Kirk serves as the Associate Director of Manufacturing (ANLY Development) at Lantheus Medical Imaging, where he plays a pivotal role in the development and optimization of analytical methods for small molecule and radiochemical products. His expertise spans the entire product lifecycle, from early-stage development through to Phase IV, ensuring that robust analytical methods are established to meet stringent regulatory standards. With a strong focus on potency assessment, low-level impurity detection, and stability-indicating techniques, Charles is instrumental in advancing Lantheus’s innovative portfolio.
One of his notable achievements includes being the author and champion of an approved Ph.Eur. monograph for an injectable product, underscoring his commitment to regulatory excellence and quality assurance. He has successfully led method development, validation, and regulatory approval processes for both drug substances and drug products, ensuring compliance with industry standards such as GLP and 21 CFR Part 11. His leadership in aseptic manufacturing process technical transfers and commercial process validations has been critical in maintaining high-quality manufacturing controls and site qualifications.
Charles's proficiency in analytical chemistry, particularly in spectroscopy and gas chromatography, complements his strategic approach to Quality by Design (QbD) principles. As a lead author of CMC dossiers, he has optimized methods for commercialized products, driving efficiency and reliability in manufacturing operations. His collaborative spirit and technical acumen position him as a key figure in Lantheus Medical Imaging’s mission to deliver safe and effective imaging solutions, ultimately enhancing patient care in the medical field.
Associate Director Mfg. ANYL Development in Mfg. Technology (Ops) at Lantheus in July 2011 to Present
Director Of Manufacturing Analytical Development at Lantheus in October 2016 to Present
Senior Director of MSAT (Mfg. Science & Technology) and CMC at Lantheus in January 2022 to Present
Group Leader-Analytical Development at Vertex Pharmaceuticals in December 2008 to August 2011
Group Leader in Commercial Support & Lifecycle Management at Vertex Pharmaceuticals in November 2007 to December 2008
Research Investigator II at Bristol-Myers Squibb in January 2003 to December 2007
Drug Product Analyst at Rhone Poulenc Rorer in January 1995 to January 1997
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Radiopharmaceuticals
theranostics
21 CFR Part 212
Spectroscopy
Validation
Technology Transfer
Statistics
Quality by Design
Qualification of CMOs
Analytical Chemistry
GMP
GLP
LC-MS
FDA
Biopharmaceuticals
Chemistry
Sop
R&D
21 CFR Part 11
GxP
Drug Development
V&V
Gas Chromatography
CRO
Dissolution
SOP
CRO Management
Standard Operating Procedure (SOP)
Verification and Validation (V&V)
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Discover more about LantheusWhat is Charles Kirk email address?
Email Charles Kirk at [email protected] and [email protected]. This email is the most updated Charles Kirk email found in 2026.
What is Charles Kirk phone number?
Charles Kirk phone number is +17176086662.
How to contact Charles Kirk?
To contact Charles Kirk send an email to [email protected] or [email protected]. If you want to call Charles Kirk try calling on +17176086662.
What company does Charles Kirk work for?
Charles Kirk works for Lantheus
What is Charles Kirk's role at Lantheus?
Charles Kirk is Associate Director Mfg. ANYL Development in Mfg. Technology (Ops)
What industry does Charles Kirk work in?
Charles Kirk works in the Pharmaceutical Manufacturing industry.
Charles Kirk Email Addresses
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