Experience

Lifecore Biomedical

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Analytical Development Manager

  • Jun 2022 - Present

  • Functional manager responsible for all method development, validation, transfer, and clinical testing (release and stability) activities at Lifecore

• Analytical Development Supervisor

  • Jun 2019 - Jun 2022

  • Functional manager responsible for all method development, validation, and transfer activities at Lifecore • Manage a team of 10 analytical development scientists • Responsible for all process development support testing (non-GMP) and early-phase clinical testing (GMP) • Manage resources to ensure development and validation activities are performed in accordance with client requirements and to meet agreed upon timelines • Represent analytical development team for internal and… Show more • Functional manager responsible for all method development, validation, and transfer activities at Lifecore • Manage a team of 10 analytical development scientists • Responsible for all process development support testing (non-GMP) and early-phase clinical testing (GMP) • Manage resources to ensure development and validation activities are performed in accordance with client requirements and to meet agreed upon timelines • Represent analytical development team for internal and external audits • Lead staff, and serve as subject matter expert resource for direct reports and others in company •Maintain and manage customer relationships — intervene to assist direct reports when necessary •Perform root cause investigations, assess impact, and determine corrective actions •Troubleshoot equipment and method failures •Support continuous improvement efforts: Labware LIMs implementation, Empower custom field development, analytical capability expansion

• Associate Scientist

  • Jun 2018 - Jun 2019

  • Served on a core team responsible for all new technology development projects • Responsible for all aspects of analytical testing for projects at multiple clinical phases • Actively participated in client meetings and supported a variety of client requests • Direct supervisor for 3 method development chemists

• Validation Chemist III

  • Jul 2016 - Jun 2018

  • Performed method validation, verification, and transfer activities primarily focused on chromatographic methods in accordance with applicable regulatory guidelines • Authored validation protocols and reports • Coordinated and authored documentation associated with equipment change in CATSWeb • Utilized Excel and Minitab to analyze and trend validation and development data • Designed and verifyed custom field calculations in Empower chromatography software • Submitted… Show more • Performed method validation, verification, and transfer activities primarily focused on chromatographic methods in accordance with applicable regulatory guidelines • Authored validation protocols and reports • Coordinated and authored documentation associated with equipment change in CATSWeb • Utilized Excel and Minitab to analyze and trend validation and development data • Designed and verifyed custom field calculations in Empower chromatography software • Submitted improvement ideas to the corporate Continuous Improvement Team • Updated analytical methods utilizing the company change order process

• QC Chemist II

  • Dec 2014 - Jul 2016

  • Responsible for performing the majority of chromatographic tests in the QC Lab • Performed in-process (STAT) and final product release testing on pharmaceutical powders and filled syringes in a cGMP environment • Performed investigational testing for OOS/OOT investigations • Active member of the QC laboratory safety committee • Participated in method transfer activities for a polarimetry method



3M

• United States
• Industrial Machinery Manufacturing
• 700 & Above Employee

• Analytical Chemist

  • Oct 2010 - Dec 2014

  Performed a variety of analytical techniques, including: particle size distribution, through-life dose content uniformity, drug content assay, water content by Karl Fischer coulometry, and foreign particulate content by light obscuration. Performed all testing in a GMP/GLP environment. Quantified analytical samples with reverse phase HPLC and GC. Utilized Empower software to integrate chromatograms and process data. Contributed to the method optimization of existing… Show more Performed a variety of analytical techniques, including: particle size distribution, through-life dose content uniformity, drug content assay, water content by Karl Fischer coulometry, and foreign particulate content by light obscuration. Performed all testing in a GMP/GLP environment. Quantified analytical samples with reverse phase HPLC and GC. Utilized Empower software to integrate chromatograms and process data. Contributed to the method optimization of existing foreign particulate method. Performed routine calibration and maintenance on equipment to ensure proper operation. Responsible for performing pre-audit review of 12 months of stability data. Performed investigations on suspect results and drafted reports summarizing the investigation and the findings of the investigation. Determined labor cost estimates for research proposals to partner company. Show less Performed a variety of analytical techniques, including: particle size distribution, through-life dose content uniformity, drug content assay, water content by Karl Fischer coulometry, and foreign particulate content by light obscuration. Performed all testing in a GMP/GLP environment. Quantified analytical samples with reverse phase HPLC and GC. Utilized Empower software to integrate chromatograms and process data. Contributed to the method optimization of existing… Show more Performed a variety of analytical techniques, including: particle size distribution, through-life dose content uniformity, drug content assay, water content by Karl Fischer coulometry, and foreign particulate content by light obscuration. Performed all testing in a GMP/GLP environment. Quantified analytical samples with reverse phase HPLC and GC. Utilized Empower software to integrate chromatograms and process data. Contributed to the method optimization of existing foreign particulate method. Performed routine calibration and maintenance on equipment to ensure proper operation. Responsible for performing pre-audit review of 12 months of stability data. Performed investigations on suspect results and drafted reports summarizing the investigation and the findings of the investigation. Determined labor cost estimates for research proposals to partner company. Show less



University of Minnesota

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate TA

  • Sep 2008 - May 2010

  · Worked with international graduate students on their spoken English. · Taught in a variety of settings, including: lectures, workshops, and language laboratories. · Facilitated small group discussions and taught portions of the lectures. · Assisted students with their individual language difficulties. · Provided written feedback to address students’ specific language needs. · Worked with international graduate students on their spoken English. · Taught in a variety of settings, including: lectures, workshops, and language laboratories. · Facilitated small group discussions and taught portions of the lectures. · Assisted students with their individual language difficulties. · Provided written feedback to address students’ specific language needs.