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AUDREY TURNER

914-***-****

adzjfe@r.postjobfree.com

Please accept this letter and attached resume as my expressed interest in joining your organization in a position suitable to my professional qualifications. My background includes extensive experience and training in project management. With this experience, we can work together to advance the mission of this company. As my resume reflects, I have extensive practical experience and formal training in this area. Furthermore, this experience is complemented by strong administrative and analytical skills, including an MBA that enhanced my management and marketing experience. With this background, I am confident that I will make a valuable addition to your organization. I feel that your facility would offer me a challenging and rewarding experience. Should you need additional information, or to schedule an interview, please feel free to contact me. Thank you for your time and courtesy in reviewing this material. I look forward to your forthcoming response. Sincerely,

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SUMMARY OF QUALIFICATIONS

Background includes experience and training in these key areas:

Pharmaceutical products, Project Management, Knowledge of both MS project and Smartsheet, using both Gantt chart and PERT chart, audits, laboratory procedures, quality control, pre-clinical testing, compliance, technical writing-test protocols, reports/documentation, cGMP, cGLP, cGCP, OSHA and FDA regulations; Computers, Microsoft Works (Word, Excel, MS Project, PowerPoint)

Change management - Analyze the overall health of y the project. Implement change. Improve performance. Leadership and employee engagement.

Program management – multitask on several project, manage scheduling, risk management, decision and action management manage budge.

Take charge of situations to deliver professional results; interact effectively with co-workers and the public. PROFESSIONAL EXPERIENCE

National Resilience (formerly Ology BioServices) - Alachua, Florida 9/2018 to present.

Sr. Project Manager

Ensure the Project Brief, Scope and Charter are finalized to align with the project.

Guide the project boundaries and make sure that the work stays within scope.

Schedule and conduct project and subcontractor kick-off meetings.

Ensure all stakeholders are informed on the project status and involved in any changes and decision impacting the project scope.

Plan, execute and coordinate all aspects of the project to maintain schedule, budget, scope, and quality in accordance with project requirements.

Provide project management leadership to a cross-functional Product Development Team (PDT) representing the various functional groups required to conduct the project scope of work (ex. Manufacturing, QA, QC, RA, Project Scientist, Clinical and Non- Clinical) and other stakeholders to anticipate and manage changes to projects. Help to define and execute the mission, vision, and direction for the PDT.

Create and maintain the records and historical files for the project.

Manage the project performance using Earned Value or other methods.

Assist with coordination of the development of subcontractor Statements of Objectives and Statements of Work Manage client relations and interfaced directly with client.

Knowledge of both MS project and Smartsheet, using both Gantt chart and PERT chart, creating critical path, secondary critical path and float, as well as establishing project risks.

Emergent Bio-Solutions - Lansing, MI

02/2016 to 10/2017

Specialist (Project Manager)

Managed assigned project to ensure the Quality department maintains compliance.

Led the development of a material classification corrective action to ensure quality controls are in place for GMP Materials.

Certified that products met or exceeded client expectations, by initiating feedback from customers which led to continuous improvements via Kaizen activities.

Prepared Gant charts to better monitor project scheduling.

Managed assigned project to ensure the Quality department maintains compliance.

Led the development of a material classification corrective action to ensure quality controls are in place for GMP Materials.

Certified that products met or exceeded client expectations, by initiating feedback from customers which led to continuous improvements via Kaizen activities.

Prepared Gant charts to better monitor project scheduling. Emergent Bio-Solutions - Lansing, MI

02/2013 to 02/2016

QC Microbiology Supervisor (Title changed to Manager 10/2016)

Oversee the daily activities of the QC Microbiology department.

Coordinate testing activities and associated work schedules.

Assign and monitor the training of department personnel.

Review and approve LIMS data, protocols, reports.

Led Team-building events and promoted employee self-development.

Monitor to budget for service accruals and purchase orders.

Author and approve investigations, deviations, CAPAs, and change controls.

Ensure department compliance with cGMP regulations and current procedures.

Conduct routine laboratory and facility reviews to maintain audit readiness. Page 3 of 3

Perform regular Microbiology program assessments and drive continuous improvements.

Participate in FDA and other third-party regulatory inspections supporting site operations.

Represent Quality Control on cross-functional teams and at company meetings.

Conduct personnel interviews and provide employee feedback. Leidos Biomedical Research (formerly NIC / SAIC Frederick), Frederick, MD 05/2007 to 01/2013

Microbiologist III

Conduct biological, chemical, and physical analysis on raw materials.

Work with facilities and manufacturing to enhance product output.

Develop SOPs, protocols, test methods and QC reports.

Perform instrument qualification.

Routine microbiology testing including endotoxin, bioburden and microorganism identification. Organize and coordinate the functions of the lab. Participated in lab audits.

Actavis Pharmaceutical, Baltimore, MD

8/05 to 12/06

Microbiologist III / Supervisor

Oversee the Microbiology lab personnel activities.

Conduct release of products, risk assessments and lab audits. Conducted methods to alleviate gaps.

Performed quality review of in-process and release testing documents in support of product release.

Conduct biological, chemical, and physical analysis on products during in-process and release testing. Develop SOPs, protocols, test methods and QC reports.

Ensure cGMP laboratory supports product development and manufacturing.

Conducts laboratory investigations and review testing trends.

Let continuous improvement activities.

Performed Instrument qualification.

Wyeth Research, Pearl River, NY

02/1999 to 8/2005

Training - Operations and Compliance (Research Scientist I)

Responsible for coordinating all Skills Training Aids (STA's), used to ensure that the Chemical Pharmaceutical Development (CPD) staff receive appropriate training to perform job functions.

Maintain the section's internal tracking system for STA's, which includes conducting audits of the system in Access and providing staff training via Training and Operational Procedures Database System (TOPS).

Promoted twice from prior positions of Scientist I and II

Prepared for and successfully completed all FDA audits with no citations.

Participated in the development of Wyeth's first STA's for CPD staff.

Increased productivity and compliance by developing more efficient training methods which regulated training and upheld compliance.

Knowledgeable in GMP and GLP guidelines.

Scientist II

Responsible for maintaining the Microbiology Laboratory.

Assisted with the IQ, OQ and PQ phases of equipment validation.

Conducted pre-clinical testing of product samples; testing methods included Endotoxin (using Gel Clot and the Endosafe), Sterility

(using membrane filtration and direct transfer techniques), Microbial Limit/ Bioburden (using pour plates, membrane filtration, and MPN techniques), and Water Testing.

Additional duties included clinical sample collection, identification of organisms, validation of microbial recovery, environmental monitoring of aseptic areas, reviewing and documenting laboratory data, and investigating and reporting on non-conforming product samples.

Collaborated with senior staff to generate and revise test protocols, testing methods and General Write and review technical Reports (GTR's and SOP's).

Collaborated with CPD staff to conduct internal audits of GLP/GMP labs in CPD.

Maintained and updated the LIMS System.

EDUCATION

Iona College, New Rochelle, NY

Master of Business Administration

Columbia University, New York, NY

Master of Science in Human Nutrition (pending)

Oakwood College, Huntsville, AL

Bachelor of Science Degree in Biology, Minor in Chemistry Excellent References Available Upon Request

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