David Bucklin Email and Phone Number
Camarillo, CA, US
David Bucklin's Location
Camarillo, California, United States, United States
David Bucklin's Contact Details
David Bucklin work email
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David Bucklin personal email
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About David Bucklin
I am a seasoned Operations and Quality Leader with 20+ years of experience in the Life Sciences, Specialty Chemicals, and Pharma businesses. I am passionate about the work we do and the critical nature of the products we provide to support patient health globally.I have a proven track record of leading my teams to improve the safety, quality, volume, and financial measures of every operation I have led.I am skilled at organizational design and developing others to realize the full potential of both the business and the individual.I am excited by new challenges and enjoy process improvement initiatives. I am interested in continuing my own development in the areas of Quality, Business, and Operational Strategy.
David Bucklin Work Experience Details
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Sr. Qa Manager, Incoming Materials And Clinical DistributionAmgenCamarillo, Ca, Us -
Sr. Manager, Drug Substance Quality AssuranceAmgen Apr 2024 - PresentThousand Oaks, Ca, Us
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Sr. Qa Manager, Incoming Materials And Clinical DistributionAmgen Oct 2021 - Apr 2024Thousand Oaks, Ca, Us
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Director Of ManufacturingFujifilm Irvine Scientific Nov 2020 - Oct 2021Santa Ana, Ca, UsProduction Operations Director for Cell Culture Media and associated product lines.Manufacturing Operations includes both sterile liquid and powder media processing in an ISO 13485 registered facility. -
Design Operations Manager, Cell Culture Media Global Design TeamMilliporesigma Jun 2019 - Nov 2020Burlington, Ma, UsAs the Design Operations Manager I am a member of a global leadership team responsible for the services and operations arm of the Cell Culture Media (CCM) Global Design Team. My responsibilities include: - Management of the ImMEDIAte ADVANTAGE(TM) (IA)operations globally which provides small volume / quick delivery of custom cell media formulations to the pharma and life sciences industry with operational footprint in the US, Europe, and Asia.- Management of the Technical Operations team who provide technical manufacturing support, scale-up, and troubleshooting to our customers and our internal large-scale CCM operations teams globally.- Management of the Bioservices Team who provide custom stability programs to our customers enabling establishment of expiry dating / retest dating for custom cell media formulations. Bioservices also provides analytical testing for customers seeking additional information on spent media or for process development purposes beyond what is provided on a release Certificate of Analysis.- Business Analytics and Program Management for the Global Design TeamI also collaborate closely with Marketing and Sales Development business partners to develop and continuously improve the Bioservices and IA Operational strategies and our products and services provided to internal and external customers. As a member of the Global Design Team Leadership Team, I work closely with my colleagues and Operations senior management to build new and innovative processes which enables the GDT to bring our customers formulations to life in our manufacturing systems. -
Project ManagerMilliporesigma Oct 2018 - Jun 2019Burlington, Ma, UsImplementation Project Manager for Cell Culture Media scale up and enhanced customer offering.My main responsibility during my time in this role was to create and launch a new business unit within the Cell Culture Media Operations team. This new team is called the Cell Culture Media Global Design Team and it launched in June of 2019. The Global Design Team (GDT) is designed to encompass the full customer experience and requirements for bringing in new opportunities to the CCM cluster. This is accomplished by directing the new product introduction process holistically through working with our customers media formulations and building our internal manufacturing and quality systems to enable ongoing large-scale manufacture of their media. I created the GDT through the following activities and responsibilities:-Design a global organization through combining several existing site-based teams under a single organizational structure- Create four new roles for the team - Program Manager, Business Analyst, IA Project Manager, and Design Engineer.-Define each role in the new organization by creation of 17 new job descriptions to cover every role (new and existing).-Develop and deliver a proposal and gain approval from senior management for Operations, R&D, and Commercial for the new organizational design and movement of personnel from R&D into the new team.- Advise on placement of staff into key and leadership roles within the new team.- Build and execute the detailed roll out plan including a progress scorecard based on People, Systems, and Communications.The Global Design Team is now fully operational and has made a demonstrable impact on our business and the customer experience.
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Site DirectorMerck Group Nov 2015 - Oct 2018Darmstadt, DeResponsible for operations of a manufacturing facility designed to deliver aseptically filled liquid cell culture media and buffers and dry powder media to the global healthcare industry.Directly responsible for the manufacture of products according to relevant cGMP and ISO standards, and all established procedures, specifications, and customer requirements.Responsible for the leadership, development, and performance of ~150 Operations, Maintenance, Engineering, EHS, Supply Chain, and Quality staff.Liaise with Sales and Marketing to ensure delivery of product to customers that meets their timelines and quality requirements, on time and in full.Develop and manage multiple departmental budgets and ensure controllable costs, capital spend, and revenue / profitability results are on target.Develop and report metrics for plant operational and financial health.Lead efforts to continuously improve EHS, operations and quality systems through lean manufacturing, 5S, and process improvement initiatives. -
Plant Operations ManagerSafc Apr 2014 - Nov 2015St. Louis, Mo, UsDirectly responsible for day to day operations of a manufacturing facility designed to deliver aseptically filled liquid cell culture media and buffers to the global healthcare industry.Directly responsible for the manufacture of aseptic products according to cGMP, ISO, and all established procedures, specifications, and customer requirements.Responsible for the leadership, development, and performance of 70 Operations, Maintenance, Engineering, and Quality staff.Liaise with Sales and Marketing to ensure delivery of product to customers that meets their timelines and quality requirements.Develop metrics for plant health and report to upper management regularly. Develop and manage multiple departmental budgets and ensure controllable costs and capital spend are at or below budgetLead efforts to continuously improve production operations and quality systems through lean manufacturing, 5S, and process improvement initiatives -
Production Manager - Broadway SiteSafc Dec 2011 - Apr 2014St. Louis, Mo, Us
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Product Engineering SpecialistSafc Jun 2009 - Dec 2011St. Louis, Mo, UsLiaise with site Quality, Sales and Marketing, Customer Service,Operations, and customers to develop specifications for media and serum products Lenexa team lead for Centers of Excellence project. Responsible for managing the transfer of all DPM products into Lenexa.Direct the daily activities of two Product Engineering Analysts and one contract employee Process change controls to existing specifications and batch records using MRP and electronic document systems (EDMS) Maintain routings and other MRP aspects to achieve product standard costing and inventory control Create Item Masters, Bills of Materials, and Batch Records for new and existing cell culture media and serum products
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Production SupervisorSafc Biosciences Jul 2005 - Jun 2009St. Louis, Mo, UsDirectly responsible for the manufacture of aseptic products according to cGMP and all established procedures and specificationsResponsible for the supervision, development, and performance evaluation of serum operations staffManage departmental budget and ensure controllable costs are at or below budgetContinuously improve production operations and quality systemsMaintain department in a state of audit readiness and take lead role in customer facility auditsEnsure department is operated in a state of validation. Validated systems include aseptic filling suite, autoclave, CIP and SIP circuits, and personnel aseptic gowning practices -
Quality Control AssociateJrh Biosciences Jun 2001 - Jul 2005Responsible for all biochemical testing on raw materials and finished productPerformed a large array of microbiological tests including USP sterility, Mycoplasma, bioburden, and environmental monitoring according to USP and EP test methodsWrote and collaborated in the development of SOPs, validation protocols, and other controlled documentsProcured, operated, and maintained four HPLC systems and other lab instrumentationDeveloped and validated HPLC Amino Acid Analysis methodProvided leadership and training for other QC Analysts
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Research AssistantBayer Cropscience 1996 - 2000Leverkusen, North Rhine-Westphalia, DePerformed residue analysis studies on various crop matricesExperience with LC/MS/MS, GC/MS, and HPLC analysisConducted all studies according to GLP for submission to the EPASupervised two contract techniciansMaintained laboratory instrumentationExtracted and assayed radiolabeled compoundsCreated and modified complex spreadsheets to analyze and report dataTrained new technicians on extraction procedures and instrumentationReviewed data for accuracy and completeness and assembled into report formatEarned Quality Excellence Award for work on a high profile compound -
Vet TechPrairie Village Animal Hospital 1994 - 1996Vet Tech - 1st job out of college. Helped with surgeries and post-op care of companion animals. Took phone calls and scheduled patients. Performed basic daily accounting. Performed boarding kennel duties. Inventoried and ordered supplies, medicines, and food.
David Bucklin Skills
Gmp
Biotechnology
Validation
Quality Assurance
Technology Transfer
Process Improvement
Manufacturing
Sop
Quality System
Biopharmaceuticals
Life Sciences
Management
Aseptic Processing
Capa
Project Management
Standard Operating Procedure
Pharmaceutical Industry
Business Process Improvement
David Bucklin Education Details
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University Of IowaGeneral
Frequently Asked Questions about David Bucklin
What company does David Bucklin work for?
David Bucklin works for Amgen
What is David Bucklin's role at the current company?
David Bucklin's current role is Sr. QA Manager, Incoming Materials and Clinical Distribution.
What is David Bucklin's email address?
David Bucklin's email address is da****@****ial.com
What schools did David Bucklin attend?
David Bucklin attended University Of Iowa.
What skills is David Bucklin known for?
David Bucklin has skills like Gmp, Biotechnology, Validation, Quality Assurance, Technology Transfer, Process Improvement, Manufacturing, Sop, Quality System, Biopharmaceuticals, Life Sciences, Management.
Who are David Bucklin's colleagues?
David Bucklin's colleagues are Joe Mong, S. Talese O'leary, Upal Patel, Alan Hao, Rachel Guha Roy, Jeremy Hiatt, Sarah Tamayo.
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