Jim Klancke Email & Phone Number

Maple Plain, Mn, Us

San Diego, California, United States

Head of analytical development on dynamic CMC team at biopharmaceutical company focused on developing and commercializing therapeutics in disease areas of PAH and PH-ILD.

Provided analytical CMC leadership and support to multiple small and mid-sized companies developing NCE’s, specialized dosage forms, and drug-device combination products in all development phases.

Greater Minneapolis-St. Paul Area

Independent consultant to the pharmaceutical industry providing expertise in all aspects of analytical method development, validation, problem-solving, analysis, stability, as well as laboratory compliance, documentation and quality. Full CMC analytical support for NDA, IND, ANDA, supplements, and deficiency letters. Experience with broad range of instrumental methods and techniques, including chromatography (HPLC, GC), FTIR and UV/vis spectroscopy, ELSD, dissolution and drug release, Karl Fischer, and USP methods of analysis. Career experience in drug delivery product development, specifically fast-dissolve ODT, abuse deterrent, buccal and sublingual solid dosage forms, effervescent products and polymer coating of drug particles for modified release or taste-masking.

Cima Labs, Subsidiary Of Teva Pharmaceuticals (And Formerly Cephalon Inc.)

Proven technical and administrative leadership of analytical method development, validation, stability, and Quality Control teams for drug delivery formulation concepts from Phase I clinical through marketing approval and commercialization. Developed systems emphasizing GMP and CFR 211 quality focus (SOPs, deviations management, CAPA, quality metrics, cleaning verification) resulting in strong GMP posture and successful audit record.Drug delivery specialization for product development of new therapeutic entities. Solid oral dose, especially orally disintegrating tablets (numerous ODT Rx and OTC products), buccal (Fentora), sublingual, fixed-dose combination products, and abuse-deterrent (Vantrela) forms. Formulation and material characterization using HPLC, GC, spectroscopy, dissolution, particle analysis, and various in vitro methods. Experience authoring, reviewing, and maintaining all CMC regulatory aspects including IND, NDA, CTD, and non-US submissions.Relentless focus on speed, QbD, method robustness, continuous improvement and best practices, thoughtful data analysis, and risk assessment. Sponsored multiple lab informatics initiatives and expansions including Labware LIMS, NuGenesis ELN, and Waters Empower to fully operational status. Enhanced laboratory capabilities annually, and maintained employer turnover of just 5%.

Tippecanoe, Lafayette In

Methods development and analysis for new chemical entities (API), pivotal intermediates, and new raw materials in support of chemical process development and pilot plant operations. HPLC with multiple detection modes, GC, in situ process FTIR, and other techniques applied to thorough characterization of cephalosporins, SSRIs, and muscarinic agonists.

Ms, Analytical Chemistry

Activities and Societies: Sigma XiElectronanalytical chemistry, specifically the physical, chemical, and electrochemical properties.

Bs, Acs Chemistry

Undergraduate research in electrochemistry