Experience

SHINE Technologies

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Sr Director Quality and Regulatory

  • Sep 2023 - Present

  Sr Director Quality and Regulatory position will focus on SHINE Technologies’ production of GMP compliant radio chemicals with the facilities in Wisconsin with plans to expand into Europe. This role will lead our quality initiatives and work across all departments to ensure compliance to SHINE’s Quality Systems in a Global Market. This person will lead our regulatory submission processes in accordance with our internal procedures and the regulatory requirements for our various target markets. This role is accountable for ensuring company processes are adhered to and relevant quality and regulatory guidelines and timelines are considered and implemented as applicable. Show less

• Sr Quality Assurance Manager - Therapeutics

  • Feb 2020 - Sep 2023

  The SR. Quality Manager will define the quality approach for the Therapeutics team, establish and maintain the quality system, develop a quality control laboratory and support regulatory and validation requirements. This role is the pivotal role in establishing and maintaining the cGMP requirements for the Therapeutics organization. A strong background in establishing quality organizations and coaching those not versed in this field. Maintain the Therapeutics Quality Management System department. Develop quality control function including designing laboratory, overseeing equipment purchase, and installation and staffing. Oversee Validation Activities for Clinical and Commercial site operations. Manage Regulatory aspects of the Therapeutics business as it relates to GMP activities. File the DMF with the FDA and update as required. Show less



Shine Medical Technologies, Therapeutics

• Janesville, Wisconsin, United States

• Quality Assurance Manager

  • Feb 2020 - May 2022

  Responsible for defining and building the Quality Systems, Quality Control Laboratory and support Regulatory requirements. Responsible for CAPA, Change Control, Investigations, Deviations and Document Control. Develop a Supplier Qualification program. Oversee validation and qualification activities. Responsible for defining and building the Quality Systems, Quality Control Laboratory and support Regulatory requirements. Responsible for CAPA, Change Control, Investigations, Deviations and Document Control. Develop a Supplier Qualification program. Oversee validation and qualification activities.



University of Wisconsin-Madison

• Higher Education
• 700 & Above Employee

• Adjunct Professor

  • Jan 2018 - Dec 2021

  Lecturer for Biotechnology Operations course in the Masters for Biotechnology Program. Lecturer for Biotechnology Operations course in the Masters for Biotechnology Program.



Lyophilization Services of New England (LSNE-Madison)

• Madison, Wisconsin

• Director Of Quality Assurance

  • Apr 2018 - Feb 2020

  Responsible for leading all Quality Assurance (QA) functions at LSNE-Madsion to include: Ensuring the manufacture of each client's products are in compliance with Good Manufacturing Practices (GMP) and are appropriate quality for their intended use; Quality oversight of the entire Contracted Manufacturing Organization (CMO) functions at LSNE-Madison; Liason of quality related issues with LSNE-Madison's Chemistry, Manufacturing, QC and Management Teams; and Directing the QA, QC and Validation operations including staffing, budgeting, setting goals and priorities. Show less



BioTechnique

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, QA

  • Oct 2015 - Apr 2018

  Responsible for leading all Quality Assurance (QA) functions at BioTechnique to include: Ensuring the manufacture of each client's products and BioTechnique's nanotechnology products are in compliance with Good Manufacturing Practices (GMP) and are appropriate quality for their intended use; Quality oversight of the entire Contracted Manufacturing Organization (CMO) functions at BioTechnique; Liason of quality related issues with BioTechnique's Chemistry, Manufacturing, QC and Management Teams; and Directing the QA operation including staffing, budgeting, setting goals and priorities for the QA department. Led implementation for an electronic quality management system (ACE) to include: Change Control, Deviations, SOP, Training, Environmental Monitoring and Trending, Out of Specifications, Internal Audits and Tracking QC Samples. Oversaw QC and Validation departments to include the purchase and validation of QC equipment and validation of all production equipment and utilities. Drafted the Validation Master Plan for the site. Show less



Kleen Test Products Corporation

• United States
• Manufacturing
• 200 - 300 Employee

• QA Validation Department Head

  • Jan 2014 - Oct 2015

  Guide the validation department in drafting and execution of IQ, OQ, PQ and PV protocols for OTC pharmaceuticals and medical devices. Ensure efficient transfer of processes and products into the manufacturing department to support OTC pharmaceutical and medical device manufacturing. Support validation activities at multiple company sites. Work with Project Management to develop detailed timelines for transfer of manufacturing processes into KTP. Use lean six sigma and continuous improvement techniques to improve manufacturing process activities and reduce waste. Revised the Validation Master Plan and Validation Cleaning Master Plan to reflect ISPE guidelines. Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Facility and Manufacturing Operations

  • Dec 2004 - Oct 2013

  Direct the manufacturing upstream, downstream, facility operations, materials management, maintenance, EHS and equipment and facilities validation. Responsible for all cGMP manufacturing which include mammalian cell culture and protein purification operations. Core team member for design and construction of a new biopharmaceutical facility. Led efforts for process design and equipment selection which includes the use of single use systems. Led the site efforts for the construction design of a phase I/II. Assisted in execution of the design to construct a new phase I/II GMP manufacturing site. Led site efforts for the validation of this new Biomanufacturing site. Team member for selection and implementation of single use disposable manufacturing systems. Formed a GMP manufacturing infrastructure for: Upstream, Downstream, Cell Banking, Materials, Facilities, Environmental Health and Safety and Metrology, which included hiring a department supervisor for Manufacturing Operations, implementing training programs, drafting SOPs and hiring appropriate staff. Worked with Quality Assurance department to develop and implement a quality infrastructure to meet cGMP regulations. Led the efforts for drafting a Validation Master Plan, drafted and executed protocols for validation of a contract manufacturing facility to produce proteins for phase I/II clinical trials. Led the Materials department in the implementation of a MRP system. Improved and implemented a manufacturing flow method for the GMP operations to allow for a more unidirectional flow of personnel and materials. Lead the Upstream and Downstream Manufacturing groups for the cGMP production of Phase I/II clinical product. Ensure efficient tech transfer of cell culture and protein purification procedures for the cGMP production of Phase I/II clinical product. Completed training for Lean and Six Sigma concepts. Led the effort for implementation of visual control boards and 5S activities. Show less



PowderJect Vaccines

• Biotechnology Research

• Director, Manufacturing Operations

  • 1998 - 2004

  Direct the manufacturing activities for the production of DNA vaccines. Manage the transfer of new DNA powder vaccine formulation and delivery device from process development into GMP manufacturing. Led efforts for the validation of a new facility. Direct the manufacturing activities for the production of DNA vaccines. Manage the transfer of new DNA powder vaccine formulation and delivery device from process development into GMP manufacturing. Led efforts for the validation of a new facility.



BD Biosciences (DIFCO) Laboratories

• Plant Manager/Production Manager

  • Aug 1987 - Jun 1998

  Managed plant operations and production during the BD-DIFCO transition. Directed all production activities through 5 direct reports. Hired, trained and managed the performance of 50 employees in multi-shift manufacturing activities. Coordinated the design, installation, and validation of equipment and processes in a new manufacturing facility for medical diagnostic devices. Managed plant operations and production during the BD-DIFCO transition. Directed all production activities through 5 direct reports. Hired, trained and managed the performance of 50 employees in multi-shift manufacturing activities. Coordinated the design, installation, and validation of equipment and processes in a new manufacturing facility for medical diagnostic devices.