Operations Expert · People Leader

Highly accomplished strategic leader with 15 years of progressive experience in the biopharmaceutical industry. An outspoken leader with the know how to drive performance while maintaining integrity and promoting growth and delivery. The balance between technical, tactical, strategic and human decision making and performance to ensure the success of the company, clients, employees and most importantly the patient. This can only be accomplish through controlling complex projects, decisive decision making, critical thinking with a focus on establishing and using representative data.

IDT-Biologika l Rockville, MD l January 2023 – Present

Director of Manufacturing and Technical Operations

Reporting to Senior Vice President/ Managing Director of IDT-Biologika North America site. Accountable for the development of strategic direction for Manufacturing, Manufacturing Support, Manufacturing Science and Technology, Site Training, EHS, Material Management to drive decisions in support of overall business strategy and company revenue goals for North America.

Site Leadership Team

Refinement of CDMO contract structure and costing model resulting in a 30% increase to project costing by embedding OPEX and contract margins within the contract management negotiations. A 50% reduction in onerous contracts and break-even contracts with additional pass-through costing capabilities.

Increase of capacity utilization by 39% with a reduction in facility downtime of 70% while achieving a 100% batch success rate for 8 different product owning companies of various uses (CTM, MCB, RSS, DP).

Sponsor for capacity improvement project which would facilitate additional revenue generating projects by 50% with minimal CAPEX expense and more robust cleanroom controls suitable for EU regulations.

Monthly engagement of client leadership teams (executive and upper management) through joint steering committees to improve client relationships, build trust, manage escalation and top problems in the performance of the manufacturing process

Key stakeholder in the establishment of site objectives and strategy with the deployment of a revised site strategy and objective establishment to increase site revenue and continuous improvement.

Technical Leadership

Lead a 25% reduction in production to release cycle times and reduction of 60% in overdue trainings, increase deviation rate of 60% with a 50% reduction in client identified quality events.

Complex problem resolution of manufacturing science, equipment, compliance events to facilitate batch release (current and legacy batches) across matrix team of 50+ members/ 6 functions.

Development of European Union (EU) compliant drug substance aseptic process simulation (APS) and refinement of site drug product (2 independent APS processes) and cell banking (1 independent APS process) validation program to improve to 100% compliance with APS requalification.

Development of internal technology transfer process to balance technical, contractual, and client requirements. The establishment of a standard technology transfer process, timelines, client interfacing milestones and governance.

GlaxoSmithKline l Rockville, MD l August 2014 – January 2023

Associate Director of LSM Production l October 2019 - January 2023

Reporting to Value Stream Director of Rockville Large Scale Manufacturing (LSM) Production. Managing the operational performance of Manufacturing to produce commercial drug substance ensuring adherence to all market regulations and safety procedures.

Strategic Leadership

Leader of site Extended Leadership Team (ELT) with co-ownership of strategy and resolution of site top problems. The establishment of cultural tools and participation in site councils including quality, finance, supply chain.

Accountable for the performance of the manufacturing process with a team of 40+ members of Upstream (Oct 19 – Jul 22) and Downstream (Jul 22 – Jan 23) for BENLYSTA® (belimumab), Nucala® (mepolizumab), ABthrax® (Raxibacumab), and other commercial phase products with a 92% capacity utilization.

Utilization of change management approaches to drive organizational change impacting 100+ manufacturing employees to consolidate the department from 3 sub-organizations (Upstream, Downstream, Production Support) to 2 sub-organizations (Upstream and Downstream).

Member of the site production M-ERP Implementation project team, Change Control Review Board (CCRB), Raw Materials Board (RMB), Deviation and CAPA Review Board.

Technical Leadership

Lead a 25% reduction in production to release cycle times and reduction of 60% in overdue trainings, increase deviation rate of 60% with a 50% reduction in client identified quality events.

Complex problem resolution of manufacturing science, equipment, compliance events to facilitate batch release (current and legacy batches) across matrix team of 50+ members/ 6 functions.

Development of European Union (EU) compliant drug substance aseptic process simulation (APS) and refinement of site drug product (2 independent APS processes) and cell banking (1 independent APS process) validation program to improve to 100% compliance with APS requalification.

Development of internal technology transfer process to balance technical, contractual, and client requirements. The establishment of a standard technology transfer process, timelines, client interfacing milestones and governance.

Senior Production Supervisor l November 2018 - October 2019

Tactical Oversight

Oversight of a shift of 6+ manufacturing associates performing upstream manufacturing operations at the 20,000L scale. Governance of team performance through the ownership of middle management governance forums to establish consistent high-quality performance, cross functional support requirements, operation scheduling and task assignment.

Establishment of lean training structure to manage new hire training and established employees learning journey. 20% reduction in overdue training to facilitate knowledge-based training progression to balance individual employee needs with business risks.

Quality system approver for department deviations, CAPA’s, and change controls utilizing GMP compliant problem-solving tools and process improvements to embed “voice of the customer” into the established program.

Leadership of site projects aligned to organizational strategy including the implementation of the GlaxoSmithKline Production System (lean 6-sigma), M-ERP implementation (Production Execution SME), audit preparations, supplemental support of other value stream manufacturing organizations to support on time, zero defect batch completion.