BENJAMIN BUCKLEN

Shoreview, MN 920-***-**** ad1za4@r.postjobfree.com linkedin.com/in/benjamin-bucklen-26b6a551

Graduated with BS in Biology in 2011 from UW Platteville

CHEMIST/QUALITY ENGINEER

Exceptional proven experience achieving company goals and maintaining a high level of quality and value of the products. Impactful leader utilizing validation and verification of test methods, drug formulation, and product efficacy. Excels at learning new techniques, exploring data, and implementing production solutions to problems. Core competencies include:

Good Lab Practices Good Documentation Practices aseptic technique CFR regulations ICH guidelines

Quality Assurance Training Coaching and Mentoring Operations Consultation Regulatory Compliance

IQ/OQ/PQ TMV PPAP review and execution

AREAS OF EXPERTISE

Dynamic Group – July 2022-Current

•Write protocols and reports for new product development and validations

•Collect and analyze data for product capability and test method validations

•In charge of supplier CAPA’s and complaint mitigation

•Interfacing directly with the customer to evaluate specification changes and product modifications

•Working both internally and with customers to establish timelines for the execution of validations and qualifications.

•IQ/OQ/PQ – Analyzing data for manufacturing capability

•TMV – Writing protocols and reports, designing methodologies for measuring parts, analyzing data

•PPAP execution and review

Medtronic – January 2017-May 2022

•Possess knowledge of sample testing including HPLC, UPLC, GC, Mass Spec, GPC, NMR, ICP-MS

•Empower 3 experience

•Involved with Pharm Forum meetings to evaluate changes and harmonization in USP and other compendial publications

•Expert in Good Lab Practices, Good Documentation Practices, aseptic technique, CFR regulations, and ICH guidelines for product and method development.

•SME in various methods including GC, GPC, and UPLC

•Worked on method transfers, compendial verifications, and equipment qualifications

•Coached others on the subjects of FTQ and COS.

•Green Belt certified

•Trained new employees on QSR and related documents

•Improved product quality and assisted in support through the independent authoring and execution of software protocols and document change orders (DCO’s)

•Involved in troubleshooting product issues, technical operations consultations, and material review board meetings

Upsher Smith – Mar 2016-December 2016

•Developed a method for quantifying ammonium acetate in hand lotion

•Worked on new method development for assay, CU, BU, and dissolution

•Collected and analyzed data for new method development using Empower 2 and 3

Wilson Wolf – November 2014-May 2015

•Implemented control systems in order to better comply with 21 CFR 820 regulations on medical devices

•Authored a number of large-scale DCO’s to address deficiencies in traceability and documentation

•Managed the company’s QC department

•Trained employees on quality system regulations and requirements

COMPUTER SKILLS

Microsoft Office Suite, Minitab, Documentum, SAP, LabWare, Empower 3

EDUCATION

Bachelors of Science, BS in Biology – Immunology Emphasis, University of Wisconsin, Platteville, Platteville, WI

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