Experience

Kiniksa Pharmaceuticals

• United States
• Biotechnology Research
• 100 - 200 Employee

• Director, Quality Control

  • Jun 2023 - Present

• Associate Director

  • Jan 2022 - Present

  Responsible for the design and implementation of Quality Control programs for commercial and late-stage clinical drug products, including combination products. Assure ongoing readiness for regulatory inspection and participate in audits and inspections. Manage stability program for select products; monitor and trend method and product data. Assure timely and accurate testing at CTLs in compliance with CGMP, established procedures and regulatory applications; select and qualify suppliers/CTLs as… Show more Responsible for the design and implementation of Quality Control programs for commercial and late-stage clinical drug products, including combination products. Assure ongoing readiness for regulatory inspection and participate in audits and inspections. Manage stability program for select products; monitor and trend method and product data. Assure timely and accurate testing at CTLs in compliance with CGMP, established procedures and regulatory applications; select and qualify suppliers/CTLs as needed. Establish and maintain sampling plans and specifications; collaborate on preparation of justification of specifications; collaborate on the phase-appropriate qualification/validation, and transfer of methods. Collaborate on the qualification of internal reference standards; maintain the reference standard program across internal laboratories and CTLs. Review and approve laboratory data and results, assuring their traceability and integrity; generate Certificates of Analysis for product release, and other certificates of GMP testing.



PPD

• United States
• Research Services
• 700 & Above Employee

• Associate Director

  • Oct 2020 - Dec 2021

  Direct oversight and management of laboratory operations team performing pharmaceutical testing for method transfer/qualification, release, quality control and stability programs. Ensures team productivity, efficiency and quality of work are maintained as well as achievement of the business financial goals. Responsible for the implementation of departmental goals, fiscal policies and key process improvements. Maintain oversight of laboratory operations to ensure compliance to regulatory… Show more Direct oversight and management of laboratory operations team performing pharmaceutical testing for method transfer/qualification, release, quality control and stability programs. Ensures team productivity, efficiency and quality of work are maintained as well as achievement of the business financial goals. Responsible for the implementation of departmental goals, fiscal policies and key process improvements. Maintain oversight of laboratory operations to ensure compliance to regulatory standards.

• Laboratory Manager

  • Jul 2018 - Oct 2020

  Direct oversight and supervision of people leaders, program managers and individual contributors in a laboratory team of >70 staff performing pharmaceutical testing for method transfer/qualification, release, quality control and stability programs. Manages work activities of the group including timelines, proposal and contract discussions, resource and capacity planning, revenue forecasting and recognition to support business objectives. Responsible for the review and approval of laboratory… Show more Direct oversight and supervision of people leaders, program managers and individual contributors in a laboratory team of >70 staff performing pharmaceutical testing for method transfer/qualification, release, quality control and stability programs. Manages work activities of the group including timelines, proposal and contract discussions, resource and capacity planning, revenue forecasting and recognition to support business objectives. Responsible for the review and approval of laboratory investigations, non-conformances and CAPAs. Provide guidance to team and others on regulatory guidelines and company SOPs. Work across department and site to foster process improvement and corporate initiatives.

• Senior Group Leader, Biopharmaceutical Services

  • Mar 2015 - Jul 2018

  Middleton, Wisconsin Responsible for oversight and supervision of staff and resources to support pharmaceutical development studies for method development, qualification, validation and stability. Manages work activities of the group, resource planning, client communication, technical document generation and review, mentoring staff and troubleshooting method or product-related issues.



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Group Leader, Analytical Development

  • Aug 2014 - Mar 2015

  Manager responsible for Analytical Development department workload, timelines and priorities to fulfill overall business needs and client expectations. Responsible for department revenue milestones and budget to meet site business goals. Provided guidance to clients regarding method performance, manufacturing product release specifications and stability protocol acceptance criteria. Served as analytical method expert for R&D and cGMP manufacturing support. Provided career development… Show more Manager responsible for Analytical Development department workload, timelines and priorities to fulfill overall business needs and client expectations. Responsible for department revenue milestones and budget to meet site business goals. Provided guidance to clients regarding method performance, manufacturing product release specifications and stability protocol acceptance criteria. Served as analytical method expert for R&D and cGMP manufacturing support. Provided career development opportunities and mentored direct reports.

• Lead Analyst

  • May 2010 - Aug 2014

  Responsible for coordinating daily activities of direct reports to ensure timelines are met. Served as technical lead for the Analytical Development and QC departments for procedures including HPLC, ELISA, cIEF, Western Blot, ELISA Binding Assays and SDS-PAGE. Transferred, developed and provided troubleshooting for internal and client methods. Wrote SOPs as needed. Prepared and reviewed method qualification protocols to ensure compliance with internal SOPs and ICH Q2(R1) requirements… Show more Responsible for coordinating daily activities of direct reports to ensure timelines are met. Served as technical lead for the Analytical Development and QC departments for procedures including HPLC, ELISA, cIEF, Western Blot, ELISA Binding Assays and SDS-PAGE. Transferred, developed and provided troubleshooting for internal and client methods. Wrote SOPs as needed. Prepared and reviewed method qualification protocols to ensure compliance with internal SOPs and ICH Q2(R1) requirements. Participated in client calls and visits to assist in fulfilling project objectives.

• Protein Purification Technician

  • May 2007 - May 2010

  Responsible for performing ELISA, HPLC, WB, SDS-PAGE and cIEF analysis of protein samples to support cell line creation, upstream and downstream process development activities. Developed and qualified HPLC analytical procedures for the characterization and analysis of various biopharmaceutical products. Prepared and reviewed applicable SOPs and qualification protocols. Trained new personnel as required.



OpGen, Inc.

• Biotechnology Research
• 1 - 100 Employee

• Laboratory Technician

  • Aug 2006 - May 2007

  Madison, Wisconsin Responsible for sample analysis and data interpretation for the assembly of whole genome consensus maps to identify unknown bacterial species. Provided general lab support and assistance in the conversion to a GMP compliant laboratory. Reviewed protocols and SOPs as applicable.



PPD

• United States
• Research Services
• 700 & Above Employee

• Scientist/QA Auditor

  • Jun 2003 - Aug 2006

  As a scientist, performed sample preparation and analysis of small molecule pharmaceutical products by LC/MS and HPLC. Compiled, reviewed and reported results to appropriate management. Project leader for several large analysis projects. As a QA Auditor, conducted data and report audits and performed in-process inspections of laboratory personnel. Reported audit findings to laboratory management and study directors.