Judith Shuster

• Lead CMC regulatory team of 27 scientists and contractors responsible for the pre-approval and post-approval regulatory strategy and content for large and small molecules, cell/gene therapy and combination products.
• CMCRA representative on Large Molecule CMC Council and PQM SLT. Adhoc member of PAM/QRB.
• Interaction with regulatory agencies for daratumumab, amivantamab, KLK2, Bowery project and products such as Duragesic (crystal formation) and Doxil (worked closely with JSC team to gain approval of 2 new sites after manufacturer closed due to a consent decree).
• Assumed responsibility for regulatory combination product team and assimilated team into department as well as defined their role. Increased department and customer knowledge of combination products through numerous training sessions.
• Significant experience with FDA Drug Shortage due to Doxil issues. Contact for FDA Drug Shortage for all stock-outs and delistings.
• Led FDA meetings on crystal issue for Duragesic to establish specification with Eric Duffy at FDA.
• Spearheaded involvement of Ethicon as the legal manufacturer of the urinary placement catheter by soliciting collaboration between Janssen and Ethicon. Established team to identify key stakeholders and processes required for successful collaboration between the companies leading to CE marking of the device.
• Fostered work culture of collaboration and inclusion to increase morale and reduce turnover. Encouraged personnel to move into different modalities to gain experience and increase their versatility.
• Leadership awards:

1. Extraordinary contribution in the development, submission, approval and launch of daratumumab

2. For Doxil filings for new manufacturing site for achieving exceptional business results by demonstrating outstanding leadership behaviors embodied in the following tenets of the Leadership Imperatives of Lead and Deliver.

3. For exceptional business results for Doxil for demonstrating outstanding behaviors embodied in the tenets of the Global Leadership Profile.

• Oversaw several early development programs leading a team with members from Chemical, Analytical and Pharmaceutical Development.
• Leader of ChemPharm team responsible for development of carisbamate from development activities through to filing preparation. Led team through the selection of the dosage form evaluating Alza's OROS product versus a conventional tablet.
• Standards of Leadership award for leadership behavior in the submission of the Carisbamate NDA.

• Led 15 CMC regulatory personnel responsible for CMC strategy and content of regulatory submissions from pre-approval through post-approval for small molecules.
• Responsible for entire department budget.
• Oversaw CMC regulatory activities for 4 therapeutic areas: Anti-infective, Anti-inflammatory,Endocrine, Metabolism.
• CMC team member for Pepcid Rx to OTC switch working with SKB.
• Responsible for regulatory filing of 6 major marketing applications for new chemical entities and line extensions.
• Selected as Drug Development Subteam Leader for major new program, Vytorin. Successfully led team from development and manufacturing to filing and had product available on shelves the day after approval working closely with Merck Manufacturing Division.
• Successfully accomplished major acceleration of Vytorin, with CMC release of regulatory filings for US, EU and rest of world on the same day.
• Selected as CMC regulatory and quality lead on joint venture program with Schering leading to two filings, Zetia and Vytorin. Identified major error in dossier for Zetia requiring Schering to send correction to FDA for their dossier. Awarded a Director's Award.
• Restructured group to increase efficiency by having scientists support both API and product regulatory issues.
• Worked closely with South African office to establish requirements for regulatory documentation for new filings.

• Built department of 32 chemists and support personnel, managed budget.
• Responsible for building lab (office, equipment, facilities, USP Water system, environmental monitoring), hiring all personnel, and transfer of analytical methods for all marketed products and select consumer products as a result of an FDA Consent Decree. Regular interactions with FDA.
• Successfully certified lab through use of 3rd party and inspected by FDA. No 483s were received which was a first time event for Parke Davis.
• Project completed within 18 months resulting in accolades and visit by COO of Warner Lambert.
• Leader of process improvement team from Analytical Methods Transfer from R & D to Operations.

• Managed 19 scientists in Analytical Development and Automation and Stability Analysis.
• Introduced use of robotics for dissolution, automated dilutions and aerosol testing. Robotic aerosol robot was developed with an engineering firm as this technology was not available yet.
• Led method development, validation and stability evaluation teams for development projects in R & D.
• Significant development and analytical experience with aerosol products( Azmacort and Nasacort).
• Led analytical team for the replacement of CFC propellants in inhalers. Presentation given at the University of Wisconsin Land of Lakes meeting for chemistry on this topic.
• Initiated statistical evaluation of all stability data.
• Selected as the lead from the development organization for a joint venture program to work with Jonas Salk and his institute to perform protein testing for an early program to develop a vaccine for HIV.
• Selected as an ad hoc member of the Project Management department due to team- building skills. Led due diligence team composed of clinical, regulatory and business development colleagues to Boehringer Mannheim in Germany.