Brian G. Keefer, Mr, Mba Email and Phone Number
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Science has always been at the core of both my learning and working careers. Twenty years in chemical and biopharmaceutical manufacturing and two masters degrees, it still holds true. I bring process knowlege to the quality systems of manufacturing while ensuring process and patient safety. Now, with an MBA I'm looking to expand my expertise to the entire business, not just manufacturing.
Novo Nordisk
View- Website:
- novonordisk.com
- Employees:
- 66807
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Sr. Supply Chain Analyst - Sap Master DataNovo NordiskRaleigh, Nc, Us
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Gmp Raw Material SpecialistNovo Nordisk Oct 2023 - PresentBagsværd, Dk
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Sr. Supply Chain Analyst - Sap Master DataNovo Nordisk Dec 2022 - Oct 2023Bagsværd, Dk
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Sr. Qa Area Specialist Ii, Raw Materials ManagementNovo Nordisk Feb 2018 - Dec 2022Bagsværd, DkReturned to the US from a 6 month expatriation to Denmark to continue work in the Raw Material Supply Process. Working with the Supply Chain group to ensure quality from suppliers through supplier audits, quality contracts, and QC testing. Raw Material QA with equipment validation and method transfer/verification for internal and pharmacoepial methods. Quality lead for SAP implementation and optimization for $2B DAPI-US greenfield project. Raw material batch release, material sampling plan creation, and LIMS data entry and trending.
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Senior Qa Specialist Ii, Raw Materials ManagementNovo Nordisk Aug 2017 - Feb 2018Bagsværd, DkWorking in the Raw Material QA Department in Device and Sourcing at the Corporate Headquarters in Denmark to define, establish, and manage the transfer activities related to the Raw Material Release Process used in the Diabetes Active Pharmaceutical Ingredient-US (DAPI-US) project. Responsibilities encompass all raw material approval across Novo Nordisk Product Supply: (Biopharmaceuticals, API, and Diabetes Finished Products). SAP and GlobalLIMS training along with implementation specialization in the raw material inventory and release process.
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Senior Qa Specialist Ii, Raw Materials ManagementNovo Nordisk Apr 2017 - Aug 2017Bagsværd, DkI transferred to Novo Nordisk DAPI-US (Diabetes Active Pharmaceutical Ingredient) in April 2017 and will be working across the Raw Material departments in Denmark and DAPI-US to define, establish, and manage the transfer activities related to the Raw Material Release Process used in the $2B US greenfield project.
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Diabetes Finished Products-Wash & Sterilization Process Group QaNovo Nordisk Oct 2014 - Aug 2017Bagsværd, DkThe Novo Nordisk Wash and Sterilization Process Group is a group of global Subject Matter Experts tasked with determining and sharing best practices across all production sites (Denmark, France, Russia, China, Brazil, and the US) specifically associated with product washing and sterilization processes. CIP/SIP, VHP, Dry Heat, and validation and trending of processes are in scope. Communication and implementation of global signals, CAPA's and optimization projects concerning sterilization processes.Position involves regular international travel and collaboration with 20% of my overall time allocated to being the Quality Assurance Representative and ensuring adherence to global regulatory bodies.
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Diabetes Finished Products - Drug Product Formulation Process Group QaNovo Nordisk Feb 2011 - Aug 2017Bagsværd, DkThe Novo Nordisk Formulation Process Group is a group of global Subject Matter Experts tasked with determining and sharing best practices across all production sites (Denmark, France, Russia, China, Brazil, and the US) specifically associated with product formulation processes. Product optimization, process transfer, and changes to product formulation are in scope. Communication and implementation of global signals, CAPA's and optimization projects concerning drug product formulation processes.Position involves regular international travel and collaboration with 20% of my overall time allocated to being the Quality Assurance Representative ensuring adherence to global regulatory bodies.
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Senior Qa Specialist, Drug Product Aseptic Production And Qc LabsNovo Nordisk May 2016 - Apr 2017Bagsværd, DkResponsible for maintaining a working an open relationship with Production, QC Chemistry and Microbiology, and other areas for the investigation of incidents, review and approval of non-conformities, validation protocols, data integrity audits, and document revisions. Role includes process/technology transfers and project management roles.I continue to differentiate myself by maintaining the responsibility of the compliance and quality for two Novo Nordisk Global Diabetes Finished Products Process Groups (see details below): Formulation and Wash/Sterilization, and sitting member of the Novo Nordisk Global Steering Group for Cleaning and Novo Nordisk Global Process Group for Sterilization.
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Process Support Specialist-Diabetes Product PortfolioNovo Nordisk Mar 2009 - May 2016Bagsværd, DkResponsible for quality assurance and change control standards are met for the aseptic production processes (Formulation, Filling, and Inspection) along with New Product/Process Validations and Process Optimization for Aseptic Formulation/Filling processes.Responsibilities and projects included but not limited to: batch impact analysis on non-conformities, co-ordination with contract lab analysis for investigations, process and equipment validation, process optimization using LEAN mindset, project management, product scale up and reformulation, regulatory filings (PAI, NDA, CBE, APR), statistical process control interpretation, work instructions, and traditional quality assurance for aseptic production (Wash/Sterilization, Formulation, Filling, Inspection) along with Quality Control.Time dedication is split between 60% to local Process Support and 40% supporting Global Subject Matter Expert Process Groups listed above.
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Process Support Specialist-Drug Product: VictozaNovo Nordisk Apr 2008 - Mar 2009Bagsværd, DkPromotion from the previous Chemist II position in the Chemistry Department at Novo Nordisk, to become the local subject matter expert for GLP-1 liraglutide (Victoza). On site training in Bagsvaerd, DK with product experts and helped execute the initial US process validation coming out of lab scale.Local activities included determining process uncertainty, process justification (local design space, QBD, PAT), and eventually Process Validation. Position merged into responsibilities with transition into current role as Process Support Specialist (Diabetes Products).
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Chemist I-IiNovo Nordisk Dec 2000 - Apr 2008Bagsværd, DkQC Chemist in which responsibilities included analysis of diabetes biopharmaceuticals: raw material testing, finished drug product and API testing. Analyses were performed by various methods including UV, FTIR, pH, AA, CE, and HPLC. Duties also included sample analysis leadtime optimizations, equipment maintenance, troubleshooting, creation/revision of analytical test procedures, and validation. Also included local system administration of the chromatography software Millennium/Empower. Implemented Six Sigma/LEAN strategies for the roll out of total cross-training of Chemists in department in all methods to allow flexibility for implementing sample analysis leadtime optimization project.
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Lab TechnicianHoltrachem (Honeywell) Oct 1999 - Nov 2000Charlotte, North Carolina, UsIn-Process and final release sampling and testing of chlor-alkali chemical production: Sodium Hydroxide, Hydrochloric Acid, Sodium Hypochorite, Sulfuric Acid and pressurized liquid Chlorine. Methods used GC, ICP, IC, titrations, and wet chemical methods. -
Molecular Biology Preparation SpecialistUniversity Of North Carolina Wilmington Jan 1999 - Oct 1999Wilmington, Nc, UsUnder the direction of Dr. Carl Lundeen, helped with general molecular biology lab duties such as: inoculation of microbial cultures, setup of gel electrophoresis analyses, autoclaving of equipment and specimens pre- and post-analysis, general lab cleanliness and organization.
Brian G. Keefer, Mr, Mba Skills
Brian G. Keefer, Mr, Mba Education Details
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North Carolina State University - College Of ManagementBiosciences Management W/ Operations And Supply Chain Management -
Nc State College Of EngineeringSchool Of Engineering
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North Carolina State UniversityUpstream Biomanufacturing
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University Of North Carolina WilmingtonBiology
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Cape Fear Community CollegeGeneral Studies And Humanities
Frequently Asked Questions about Brian G. Keefer, Mr, Mba
What company does Brian G. Keefer, Mr, Mba work for?
Brian G. Keefer, Mr, Mba works for Novo Nordisk
What is Brian G. Keefer, Mr, Mba's role at the current company?
Brian G. Keefer, Mr, Mba's current role is Sr. Supply Chain Analyst - SAP Master Data.
What is Brian G. Keefer, Mr, Mba's email address?
Brian G. Keefer, Mr, Mba's email address is br****@****isk.com
What is Brian G. Keefer, Mr, Mba's direct phone number?
Brian G. Keefer, Mr, Mba's direct phone number is +191963*****
What schools did Brian G. Keefer, Mr, Mba attend?
Brian G. Keefer, Mr, Mba attended North Carolina State University - College Of Management, Nc State College Of Engineering, North Carolina State University, University Of North Carolina Wilmington, Cape Fear Community College.
What are some of Brian G. Keefer, Mr, Mba's interests?
Brian G. Keefer, Mr, Mba has interest in Kayaking, Toyota Landcruiser Enthusiast, Homebrewing, Offroading, Lover Of Outdoors, Hiking, Camping.
What skills is Brian G. Keefer, Mr, Mba known for?
Brian G. Keefer, Mr, Mba has skills like Aseptic Processing, Cleaning Validation, Quality Assurance, Regulatory Affairs, Change Control, Gmp, Gxp, Fda Gmp, Lean Manufacturing, Validation, Lims, Technology Transfer.
Who are Brian G. Keefer, Mr, Mba's colleagues?
Brian G. Keefer, Mr, Mba's colleagues are Chad Dunkel, Fernando Del Moral, Berit Ravn, Maria Louise Lauritsen, Tracy Parker, Flavio Alexis Del Pino Castro, Duygu Özkan Ovatman.
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