Jim Munro's Location
Fort Collins, Colorado, United States, United States
Jim Munro's Contact Details
Jim Munro work email
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Jim Munro personal email
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Jim Munro phone numbers
About Jim Munro
I am a Quality Assurance Professional in the Pharmaceutical Industry focusing on Research and Development with a specific focus on specialty injectables.
Jim Munro Work Experience Details
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Director Quality ManagementTolmar Nov 2000 - PresentFort Collins, Co, Us -
Director Qa Research And DevelopmentTolmar Jan 2017 - Nov 2020Fort Collins, Co, UsQuality oversight of all R&D GxP and DEA related functions, Quality by Design (QbD) process and management of a robust risk management process for R&D. training compliance, review and approval of research and development operating procedures, device control strategy and design control for combination products, USP/EP compendia changes, 3rd party compliance of CMO’s, CROs, testing laboratories and new supplier selection.
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Director Qa -Quality ProjectsTolmar May 2016 - Jan 2017Fort Collins, Co, UsProvided analytical, formulations, and process development technical support for Quality Assurance. Instituted Quality by Design principles for the development process.
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Manager Quality EngineeringTolmar Jun 2015 - May 2016Fort Collins, Co, UsManaged the efforts of the Quality Engineering Group responsible for annual product performance reports, management reviews and facilitating the investigation process to identify Root Cause and CAPA.
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Supervisor Technical ServicesTolmar Jan 2008 - May 2015Fort Collins, Co, UsProvide oversight of investigations and customer complaints requiring technical support. Work closely with all departments to coordinate investigation activities and implement continuous improvement efforts. Perform reviews of APRs for the Quality Engineering Group as well as technical documents prepared for regulatory filings by Analytical Development. Support QA in FDA and third party audits.
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Senior ScientistTolmar Jan 2008 - 2012Fort Collins, Co, UsFacilitated the establishment of a Technical Services group and supervised three scientists in support of commercial product efforts under a Quality Assurance environment. Provide oversight of investigations and customer complaints requiring technical support. Work closely with all departments to coordinate investigation activities and implement continuous improvement efforts. Perform reviews of APRs for the Quality Engineering Group as well as technical documents prepared for regulatory filings by Analytical Development. Support QA in FDA and third party audits.
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Director Product DevelopmentTolmar 2006 - 2008Fort Collins, Co, UsDirected dermatology development efforts covering OTC, Generic and Proprietary programs. Worked closely with the business development, finance, legal and the executive team covering all aspects of the dermatology business. The dermatology research and development group consisted of 12 people, with 4 of those as direct reports managing 15+ projects.
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Director Product DevelopmentQlt Inc. 2004 - 2006Vancouver, Bc, CaDirected dermatology development efforts covering OTC, Generic and Proprietary programs. Worked closely with the business development, finance, legal and the executive team covering all aspects of the dermatology business. The dermatology research and development group consisted of 12 people, with 4 of those as direct reports managing 15+ projects. -
Manager Product DevelopmentAtrix Laboratories 2000 - 2004Managed timelines, resources and budgets on multiple projects covering OTC, generic, and proprietary projects. Participated in activities, including the development of ROIs, to move the dermatology business forward by identifying product concepts and business opportunities with our business partners,Managed 20+ projects covering analytical, formulation and process development R&D activities. -
ScientistGeneva Pharmaceuticals (Now Sandoz) 1994 - 2000Performed physical characterization and analytical method development for active pharmaceutical ingredients. Support the formulation group by providing scanning electron photomicrographs during the formulation development process. Provide analytical expertise on QA/QC investigations that requires specialized support.Provided analytical direction and support for quality assurance investigations. Interacted with Quality Assurance, Research and Development, formulation scientists, and production personnel to bring investigations to a close.Managed timelines, provided analytical expertise, and facilitated communication between analytical management, scientists, chemists, formulators and project managers. Directly involved with setting specifications based on ICH Guidelines. Ensured the successful and timely filing of ANDAs/NDA. Ensured smooth transition and timely completion of analytical testing for new product launches.
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R&D ChemistGeneva Pharmacetucals (Now Sandoz) 1994 - 2000Developed and validated finished product methods and performed routine analytical testing on pilot batches. Wrote development summary, and validation reports for filing in the ANDA. Developed and validated cleaning validation methods.
Jim Munro Skills
Gmp
R&d
Validation
Pharmaceutical Industry
Capa
Fda
Glp
Product Development
Technology Transfer
Analytical Chemistry
Hplc
Manufacturing
Biotechnology
V&v
Sop
Formulation
Chemistry
Biopharmaceuticals
U.s. Food And Drug Administration
Chromatography
Corrective And Preventive Action
Uv/vis
Standard Operating Procedure
Jim Munro Education Details
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University Of Colorado Colorado SpringsChemistry
Frequently Asked Questions about Jim Munro
What company does Jim Munro work for?
Jim Munro works for Tolmar
What is Jim Munro's role at the current company?
Jim Munro's current role is Director Quality Management at Tolmar.
What is Jim Munro's email address?
Jim Munro's email address is jm****@****mar.com
What is Jim Munro's direct phone number?
Jim Munro's direct phone number is +197023*****
What schools did Jim Munro attend?
Jim Munro attended University Of Colorado Colorado Springs.
What skills is Jim Munro known for?
Jim Munro has skills like Gmp, R&d, Validation, Pharmaceutical Industry, Capa, Fda, Glp, Product Development, Technology Transfer, Analytical Chemistry, Hplc, Manufacturing.
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