Senior Clinical Supply Chain Project Leader

Trisha D. Walker

Conway, SC ***** 302-***-**** **********@*******.*** www.linkedin.com/in/trisha-walker-55162a3

Pharmaceutical Clinical Project Management for Professional

Clinical Supply Chain Demand & Supply Management Project Change Management Matrix Leadership GMP Quality

Experienced clinical supply project management leader with a strong background in the Fortune 500 Pharmaceutical Industry, leading cross-functional teams to ensure the seamless planning, coordination, and execution of supply chain and manufacturing projects, optimizing resource allocation and meeting regulatory standards to support product lifecycle management. Adept in monitoring and tracking major changes evaluated in project development, including change initiation, impact assessment, decision making, change implementation and change closure. Proven success creating and implementing appropriate strategies and processes to achieve clinical supplies key deliverables for each project.

Therapeutic related experiences: Gene & Cell Therapy, Rare Disease, Neurology, Inflammation and Immunology Clinical supplies Subject Matters expert: GMP Drug Manufacture and Release, Pre-Approval Inspection / Audit.

AREAS OF EXPERTISE

Scenario Assessment Audit & Inspection Readiness Demand Consolidation, Batch Allocation, Stock Management and Traceability Supply Chain Management Decision-making Strategic Planning Cross-Functional Leadership

PROFESSIONAL EXPERIENCE

Sanofi US, Remote/Bridgewater, NJ 08/1998 – 06/2024

Demand & Supply Project Leader, CMC Project Management, (01/2021 – 06/2024)

Oversee GMP pharmaceutical development projects for multiple therapeutic programs to meet development and delivery goals.

Demand and Supply Leader for the first Gene Therapy product to successfully be manufactured, packaged and supplied to an ongoing clinical trial in house.

Contributed to the successful approval in the Rare Disease therapeutic area as a key contact for PAI and inspection and/or audit to provide the connection between Clinical Manufacture, Clinical Supply Operations and Regulatory.

Coordinated comprehensive scenario assessments and project change management, ensuring alignment with project strategy, regulatory compliance, and timely clinical trial supply delivery through effective demand consolidation and integration of production plans.

Active member of the Supplier Management team as member of the core project team for both Clinical Supplies and CMC. Including management and resolution of all issues to ensure compliance and right time delivery of investigational medicinal products.

Managed quality data and records in relevant quality management support systems including Veeva Vault for Quality documents such as Deviations, Investigations and Change Control, retention of all source documents for GMP packaging and labeling, CMC and Regulatory filings.

Project Manager Principal, Clinical Supply Chain Project Leader, Sanofi-Genzyme portfolio, (10/2013 - 12/2020)

Led the Clinical Supplies Project Team, sharing Project Development plan and providing feedback from Project team and sub team meetings, defining the supplies strategy for the project and providing direction to the team.

Established Clinical supplies strategy with partners, encompassing comparators and devices resulting in on time study supply delivery in compliance with cost effectiveness and quality, saving batch productions.

Performed forecasts (2-5 years) and provided rough estimations of cost and resource needs for the entire project.

Contributed to the relevant technical documentation (ex. quality agreement, technical agreement, supply agreement, pharmacy manual)

Ensured alignment between regulatory submission, supply strategy and associated production plans (DS/DP&IP).

Represented Clinical Supplies at the project team level for US and International teams.

Key contributor and organizer for PAI preparation and readiness for inspection and approval within Clinical Supplies.

Acted as the single interface with all partners for all aspects of the project as it relates to Clinical Supplies.

Set up and maintain partner service relationships to gain and retain long term customer satisfaction.

Trisha D. Walker **********@*******.*** Page Two

Site Quality Operations Representative and Release Manager (US), (01/2009 - 10/2013)

Managed logistical and quality aspects of all projects in various clinical phases of development in conjunction with the Clinical Supplies Department.

Released all drug product and investigational medicinal products following verification that clinical drug is consistent with the IND/IMPD with the FDA and EMA for worldwide clinical trials.

Worked with internal and external clinical, regulatory, and CMC project teams to assure continuous and safe packaging, shipping, and dating of monoclonal antibody for clinical study.

Wrote, implemented, and followed manufacture, packaging, and distribution procedures that comply with FDA regulations, EMA directives, Good Manufacturing Practices, and internal global and local Standard Operating Procedures.

GMP Representative for FDA and EMA Pre-Approval Inspections (PAI) and internal and partner PAI Readiness audits, including presentation of test article manufacture, packaging, and testing, and release.

ADDITIONAL EXPERIENCE

Wegmans Pharmacy, Malvern PA, Pharmacy Technician (part time), (01/2020 – 05/2024)

Performed all Pharmacy technician duties allowable within the state of Pennsylvania to include:

Receiving and processing prescriptions: taking prescriptions over the phone and in-person and entering them into a computer database.

Dispensing medications: prepare and distribute medications, ensuring accuracy in measurement, labeling, and packaging.

Managing inventory: They are responsible for maintaining inventory levels, ensuring that medications are available when needed.

Assisting customers: greet patients, assist them at the cash register, and handle insurance claims.

Communicating with healthcare providers: contact physicians' offices for clarification on prescriptions and work with insurance companies.

Sanofi US, Great Valley, PA

Quality Assurance Representative

Performed internal audits on our Quality Control group to determine compliance with FDA regulations, EU Guidelines, site SOPs and global SOPs. Tracked global temperature excursions on drug products and investigational products and applied stability assessment memorandums to decide on acceptability for clinical use.

Quality Control Coordinator

Research Investigator, Quality Control

Oversaw sampling and scheduling testing of all materials released into the global clinical trial supply from the Great Valley site, including all drug substances, drug products, excipients, packaging materials, and the final packaged investigational medications. Held weekly intradepartmental planning and resource meetings to manage workflow through group to avoid critical clinical trial supply disruptions. Full supervisory role for one employee with daily input as to the methods for testing to be employed for the remainder of the clinical trial supply testing group.

Neose Technologies Inc., Horsham, PA Research Specialist II, Analytical Chemist

Republic Environmental Systems, Hatfield, PA Laboratory Technician

EDUCATION

Bachelor of Science (BS) in Biological Sciences University of Delaware

Research Assistant, to Dr. Gary Laverty, Physiology Department University of Delaware, Newark, DE

AWARDS & RECOGNITION

Sanofi-Synthelabo Research Impact Award

For use of new technology, Near-IR, in coordination with Clinical Investigational Products Group.

PUBLICATIONS

“Selection and comparison of a tablet formulation in different blisters for their performance at Zone IV climatic conditions” Paper T-3030, Ganapathy Mohan, Richard Winokur, Christina Crowers, Trish Walker and Raymond Page, AAPS Annual Meeting and Exposition, Toronto, Canada. November 2002

“Application of monolithic columns for pharmaceutical analysis and comparison of their performance to conventional columns”, Ganapathy Mohan, Christina Crowers and Trisha Walker, Paper #335, HPLC 2002 International Meeting, Montreal, Canada. June 2002

“Column Selection and Criteria for Establishing Column Equivalency for Pharmaceutical Analysis by HPLC”, Ganapathy Mohan* and Trisha Walker. Paper# P-0333, HPLC 2001 International Meeting, Maastricht, The Netherlands, June 2001.

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