Experience

Immunomedics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director, Quality Control

  • Aug 2017 - Present

  Responsible for the strategic direction, management, and continuous improvement of cGMP Quality Control and Microbiology laboratories within Immunomedics. Accountable business representative for lab-related activities, including cross-functional partnerships and collaborations with external partners. Management of a staff of mid-level managers and individual lab personnel. Responsible for the strategic direction, management, and continuous improvement of cGMP Quality Control and Microbiology laboratories within Immunomedics. Accountable business representative for lab-related activities, including cross-functional partnerships and collaborations with external partners. Management of a staff of mid-level managers and individual lab personnel.



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director of Quality Control Technical Operations

  • Dec 2013 - May 2017

  ★ Oversaw a team of up to 15 managers and individual contributors responsible for commercial product specifications, stability, reference standards, new product introduction and all sample management at the site. ★ Established and led a team responsible for introduction of new products to the site, aligned department resources in preparation for commercial launch; directed analytical technical transfer. ★ Leveraged expertise in quality systems and best practices to continually innovate solutions aligned with the unique needs of internal and external customers. ★ Compiled and reported department quality metrics to assess performance against established standards, delivered robust systems for assurance of data integrity. ★ Responsible for the content of the commercial licensing applications relating to product specifications, stability, reference standards and viral adventitious agents safety testing. ★ Transitioned the Quality Control organization from a group primarily focused on product development to a key strategic partner supporting a global commercial drug substance supply chain operation. ☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲ ABOUT ELI LILLY & CO. Eli Lilly and Company is a global pharmaceutical company with headquarters located in Indianapolis, Indiana. The company also has offices in Puerto Rico and 17 other countries. Its products are sold in approximately 125 countries. Eli Lilly and Company is listed on the New York Stock Exchange and its shares have been a component of the S&P 500 Index since 1971.



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director of Quality Control Technical Operations

  • 2011 - 2013

  ★ Directed the activities of the Stability department and the site sample management team, responsible for product specifications, the reference standards program and adventitious viral agents safety testing for a portfolio of products in early to late-stage development and accelerated submission for commercial licensing. ★ Achieved and maintained the stability program for commercial and clinical products in compliance with ICH guidelines, launched systems for detection of stability trends, managed investigations. ★ Maintained a complaint sample management program while providing support for external manufacturing sites and up to 70 drug substance batches manufactured annually on site, contributed to successful execution of commercial process validation. ★ Led the development of product specification proposals, created justifications for commercial specifications; responsible for defining the site policy that governs adventitious agent safety testing. ★ Managed product reference standards, securing source material and managing the production and release of filled batches. ★ Defined the site policy that governed adventitious agents safety testing and managed contract viral safety testing. ★ Responsible for content of clinical trial applications, applications for commercial registration and support for responses to global Health Authorities. ☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲ ABOUT ELI LILLY & CO. Eli Lilly and Company is a global pharmaceutical company with headquarters located in Indianapolis, Indiana. The company also has offices in Puerto Rico and 17 other countries. Its products are sold in approximately 125 countries. Eli Lilly and Company is listed on the New York Stock Exchange and its shares have been a component of the S&P 500 Index since 1971.



ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company

• Biotechnology Research
• 200 - 300 Employee

• Quality Control Manager

  • 2004 - 2010

  ★ Supervised the testing laboratory supporting product development efforts for one commercialized product and a pipeline of development candidates. ★ Directed two supervisors and up to 15 analytical staff members engaged in the testing and support of clinical submissions globally. ★ Produced or reviewed IND and IMPD content for submission to global health authorities necessary to transition drug candidates to clinical trials. ★ Ensured compliance by laboratory operations with corporate best practices and cGMP regulatory requirements. ★ Led the transition of Quality Control laboratory facilities from a clinical production site to a commercial manufacturing facility. ☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲ ABOUT IMCLONE SYSTEMS ImClone Systems is a fully integrated global biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Quality Control BIochemistry Specialist

  • 1996 - 2004

  ★ Promoted from an initial role as a Biochemist to Senior Biochemist, then Investigator, culminating in a leadership position as Senior Quality Control Biochemical Specialist. ★ Managed a team of three professionals engaged in in-process, bulk drug substance and raw material release and routine facility water testing. ★ Directed a project that converted laboratory data acquisition systems to a 21 CFR compliant data network utilizing NuGenesis Archive and Agilent Chemstore/Chemserver. ☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲ ABOUT GLAXOSMITHKLINE GSK is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of pharmaceuticals, vaccines and consumer healthcare.