Summary
Overview
Work History
Education
Skills
Publications
Timeline

Jeffrey Mollica

Longmont,CO

Summary

Quality control professional with proven track record in managing and enhancing product quality and compliance. Known for successfully implementing quality systems and driving continuous improvement initiatives. Strong focus on team collaboration and achieving results, adapting seamlessly to changing requirements. Proficient in risk assessment and quality assurance methodologies. Experienced in all areas of Quality Control including:

  • Analysis and release of Incoming materials and supplier quality
  • In process controls
  • Release testing of Drug Substance and final Drug Product
  • Microbiological Control including Environmental Monitoring, Sterility and Microorganism Identification
  • Complete oversite of Stability program
  • Analytical Method development, validation and transfer

Overview

20
20
years of professional experience

Work History

Sole Proprietor

Small Business Owner
04.2022 - Current
  • Sole Proprietor of a Home-based business focusing on the financial markets.

Department Manager, Quality Control (QC)

Agilent Technologies Nucleic Acid Solutions Division (NASD)
08.2014 - 04.2022
  • Primary oversite of the Agilent Nucleic Acid Solutions Division (NASD) Quality Control (QC) department supporting clinical and commercial oligonucleotide-based drug manufacturing at two Colorado manufacturing sites.
  • The NASD QC Department includes: Analytical testing and release of raw materials, in-process intermediates, release testing of API both internally and through contract testing facilities.
  • Microbiology: environmental and process water monitoring, and Active Pharmaceutical Ingredient (API, drug substance) testing and release.
  • Stability program for both API and finished drug product.
  • Member of the Quality Leadership team for both sites.
  • Oversite of day-to-day operations of the QC departments and regulatory support to all departments.
  • Ensured quality, manufacturing and revenue goals and objectives were met including analytical testing completed with high degree of regulatory compliance.
  • Lead regulatory compliance efforts across different functional areas including quality, manufacturing, engineering, validation and contract labs.
  • Authored, reviewed and approved regulatory documents including standard operating procedures, analytical method development reports and final analytical methods, non-conformances, CAPAs, change controls, stability protocols and reports, validation protocols and reports, and contributed to CMC filing documents.
  • Provided guidance on current FDA and EU expectations for Data Integrity compliance.
  • Used continuous improvement tools to improve Quality Systems in a regulated environment.
  • Ensured laboratory instrumentation was installed, validated, operated and maintained in accordance with standard operating procedures and following FDA, and international regulations.
  • Primary role in a several successful projects including implementing LIMS, Particle identification, Microbe ID, hybrid remote work during pandemic.
  • Negotiate operating budget and final decision maker on purchasing and hiring decisions.
  • Integral in bringing both Colorado Laboratories online from start up to fully functioning.
  • Acted as a cross functional compliance coach to prepare staff to speak to regulatory authorities.
  • Lead role in multiple successful inspections with the US FDA and international regulatory agencies.
  • Excellent communication skills through internal and external channels.

Manager QC Lab Services group

Amgen
06.2013 - 05.2014
  • Managed day to day operations of the Amgen Colorado QC Lab Services Group.
  • Managed Solution Prep and Glass wash staff and Contingent Workers.
  • Provided leadership and mentored group members to facilitate positive change.
  • Resolved issues to ensure outstanding customer service.
  • Monitored Key Performance Indicators and took appropriate action to mitigate when needed.
  • Drove continuous improvement and served as Project Manager for lean initiatives.
  • Scheduled daily activities for direct reports.
  • Served as a member of the Audit Support team for high profile international inspections.

Specialist QA, QC NC/CAPA Investigations

Amgen Inc
08.2012 - 06.2013
  • Supported investigations, non-conformances and CAPAs for the QC laboratory groups.
  • Facilitated lab investigations for out of trend and unexpected results.
  • Owned Nonconformance (NC) and Corrective/Preventive Actions (CAPA) and tracked CAPA effectiveness.
  • Successfully met deadlines and Key Performance Indicators.
  • Demonstrated ability to work cross-functionally with diverse teams.
  • Direct interaction with inspectors to explain investigations and demonstrate CAPAs were effective.
  • Quality Safety Representative for 2012.

Manager QC Chemistry

Amgen Inc
06.2007 - 08.2012
  • Managed day to day operations of the QC Chemistry group.
  • Managed and trained QC analysts working 24/7.
  • Provided leadership and mentored group members to facilitate positive change.
  • Managed laboratory operations of Raw Material, in-process, stability and release testing.
  • Supported local and network Manufacturing plants.
  • Supported international product and testing expansion.
  • Facilitated method transfer between laboratories.
  • Travelled internationally to troubleshoot issues at fill/finish contract manufacturing laboratory.
  • Wrote and revised Standard Operating Procedures and Analytical Methods.
  • Explained laboratory processes and procedure to numerous international regulatory agencies.
  • Acted as data verifier and reviewer.
  • Identified and validated new and replacement laboratory equipment.
  • Ensured Key Performance Indicator metrics were met.
  • Developed/implemented several successful continuous improvement projects using lean principals.
  • Shared best practices with other Amgen sites.
  • Interviewed, selected and personnel.
  • Effectively worked cross-functionally across diverse teams.

Manager QC Bio Analytical Group

Amgen Inc
02.2006 - 06.2007
  • Managed day to day operations of the ACO QC Bio Analytical Group.
  • Managed and trained QC analysts.
  • Managed laboratory day to day operations, equipment, and workflow.
  • Supported local and network Manufacturing plants.
  • Supported Stability testing.
  • Explained laboratory processes to regulatory agencies.
  • Wrote and/or revised Standard Operating Procedures and Analytical Methods.
  • Facilitated method transfer between laboratories.
  • Acted as data verifier and reviewer.
  • Identified and validated equipment.
  • Ensured Key Performance Indicators metrics were met.
  • Developed/implemented several successful continuous improvement projects.
  • Shared best practices with other Amgen sites.
  • Worked cross-functionally across diverse teams.

Education

Master of Science - Pathology-Biochemistry

University of Oklahoma Health Sciences Center
01.1999

Master’s level classes - Business Administration

University of Oklahoma College of Business
01.2000

Bachelor of Science - Biology

Colorado State University
01.1991

Skills

  • Technical writing and Document review
  • Auditing techniques
  • Project management experience
  • Corrective action planning
  • Regulatory compliance
  • Statistical analysis proficiency
  • Cross-functional team leadership
  • Supplier quality management
  • Analytical Method Development, Validation and Transfer
  • Data review and interpretation

Publications

  • L.M. Regan, J.S. Mollica, A.R. Razie, C.T. Esmon, The Interaction between the endothelial protein C receptor is dictated by the gamma-carboxyglutamic acid domain of protein C., J Bio Chem, 272, 26279-84, 1997
  • D.J. Sterns-Kurosawa, S. Kurosawa, J.S. Mollica, G. Ferrell, C.T. Esmon, The endothelial protein C receptor augments protein C activation by the thrombin-thrombomodulin complex., Proc. Natl. Sci, 93, 10212-6, 1996
  • L.M. Regan, A.R. Razie, D.J. Sterns-Kurosawa, S. Kurosawa, J.S. Mollica, K. Fukudome, C.T. Esmon, The endothelial protein C receptor: Inhibition of activated protein C anticoagulant function without modulation of protease inhibitors., J Bio Chem, 271, 17499-17503, 1996
  • F.B. Taylor, Jr, D.K. Sterns-Kurosawa, S. Kurosawa, G. Ferrell, A.C.K. Chang, Z. Laszik, J. Mollica, S. Kosanke, G. Peer, C.T. Esmon, Anti-EPCR antibody exacerbates the hemostatic and inflammatory response to sub lethal c-coli., Submitted to Shock Congress for the June 12, 1999 meeting., 1999
  • L.M. Regan, J.S. Mollica, A.R. Razie, C.T. Esmon, The Interaction between the endothelial protein C receptor is dictated by the gamma-carboxyglutamic acid domain of protein., Thrombosis and Haemostasis Supplement, #SC-4, 1997
  • L.M. Regan, A.R. Razie, K. Fukudome, D.J. Sterns-Kurosawa, S. Kurosawa, J.S. Mollica, C.T. Esmon, Evidence for a free sulfhydryl(s) in the endothelial protein C/activated protein C receptor (EPCR)., Blood, 86, 197a, #777, 1995

Timeline

Sole Proprietor - Small Business Owner
04.2022 - Current
Department Manager, Quality Control (QC) - Agilent Technologies Nucleic Acid Solutions Division (NASD)
08.2014 - 04.2022
Manager QC Lab Services group - Amgen
06.2013 - 05.2014
Specialist QA, QC NC/CAPA Investigations - Amgen Inc
08.2012 - 06.2013
Manager QC Chemistry - Amgen Inc
06.2007 - 08.2012
Manager QC Bio Analytical Group - Amgen Inc
02.2006 - 06.2007
University of Oklahoma College of Business - Master’s level classes, Business Administration
Colorado State University - Bachelor of Science, Biology
University of Oklahoma Health Sciences Center - Master of Science, Pathology-Biochemistry

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Jeffrey Mollica