TECHLAB, Inc.

Create content for marketing collateral including:
- Whitepapers & proof sources
- Emailers
- Microsites and Landing Pages
- LinkedIn Posts
Analyze and maintain global pricing integrity across the TECHLAB product portfolio
Primary pricing point of contact for distribution partners’ local vendor contracts
Manage production forecasting for distribution (domestic & international) and direct customers

Product Manager

UNC Health Rex

Assist with maintaining inspection readiness for CAP, AABB, Joint Commission and FDA by participating in self-inspections and process and policy reviews. 
Assist with SOP reviews and edits.
Maintain familiarity with FDA, AABB, CLIA and other state and federal regulatory guidelines and proficiency testing requirements.
Analyze and interpret national standards, guidelines, regulations and laws pertaining to clinical laboratory quality management and safety.
Prepare monthly and quarterly quality metric reports for senior leadership.
Provide data for quality teams and support all Quality Improvement efforts.
Serve as a resource on regulatory issues and compliance, particularly in the areas of transfusion medicine and blood banking.

Quality Assurance Coordinator

Freelance (Self-Employed)

Experience with creation and revision of training documents, instructions for use, standard operating procedures, proof sources. Copy writing for white papers, brochures, emailers, landing sites / microsites, marketing materials, laboratory case studies, advertorial articles.

Medical / Technical Writer

Grifols

Represents Voice of Customer throughout product development process, from feasibility to commercial launch. 
Performs market research to assess customer needs, competitive risks, and long-term marketing potential of products.
Ensures product pipeline corresponds with current market needs.
Develop and maintain sales and scientific materials to train and support customer marketing and sales.
Develop and execute marketing launch plans and post launch surveillance activities.

Senior Product Marketing Manager, Donor Screening | Nucleic Acid Testing (NAT)

Blood Centers of America

Pursue and maintain business relationships that result in compliance with agreements and the optimization of the sale of plasma.
Act as liaison between customers and members, understanding and balancing needs of both and influencing members’ behavior toward fulfillment of corporate objectives, and financial and productivity goals.
Develop and implement strategies to encourage and aid members in the growth of source plasma programs and optimization of existing recovered plasma production.
Provide operational support to members in the development of new plasma operations and/or fractionator transitions.
Follow up with fractionator clients continuously and respond to fractionator client inquiries; responsible for the day to day account management of clients.
Sustain relationships with members, suppliers and customers to ensure internal and external customer satisfaction and loyalty.

Senior Manager, Plasma Operations

The Blood Connection

Establish and direct the Immunohematology Reference Laboratory for the Eastern North Carolina (ENC) Division of The Blood Connection.
Direct the distribution operations, shipping and receiving of blood and blood products from the TBC ENC Operations Center to support the transfusion needs of 25+ hospital partners in eastern North Carolina.
Manage staff of 20+ FTEs including Hospital Services Specialists, Couriers, and Reference Laboratory Techs.
Direct all day-to-day laboratory operations, including laboratory staff, work environment, and work processes.
Serve as a technical resource for reference laboratory staff and external customers to assist with resolution of complex technical issues.
Perform review of serologic investigations to ensure completeness and adherence to TBC policies and procedures.
Responsible for compliance with standard operating procedures and interpretation of test results in accordance with applicable regulatory requirements.

Director of Technical Services

Hemo bioscience

Day-to-day marketing support of the immunohematology product lines to both the selling organization and manufacturing division.
Technical Device History Record (Manufacturing Batch Record) review for finished proficiency testing and immunohematology products.
Develop and implement marketing plans, including targeted marketing campaigns.
Collaborate with senior management to develop sales tools, product launch materials, sales training tools and promotional programs.
Collaborate with Hemo bioscience personnel to develop sales tools and items in support of promotional activities creating visibility for assigned products at appropriate trade shows and other venues.
Subject Matter Expert for Hemo bioscience products and services to external and internal customers.
Member of Design Review Committee for new product design and development process, which includes specification development, design validation, clinical trials results review, design verification, and review of regulatory submissions.
Manage collateral development: case studies, whitepapers, brochures, instructions for use (IFU), advertorial articles, and technical marketing documents.
Voice of the customer within the organization; providing market insight and intelligence to design and development personnel for new products and improvements to current products.
Manage the Hemo bioscience exhibit presence as well as represent the company at relevant local, regional, and national conferences and trade shows.
Implement email marketing (iContact) and responsible for list maintenance and providing content for email marketing campaigns, promotions, and technical notifications.
Provide technical guidance and coordinated field trials for two successful FDA 510(k) submissions.
Serve as the primary sales, technical support, and product development point of contact for proficiency testing OEM customers.

American Red Cross

Direct all day-to-day laboratory operations, including laboratory staff, work environment and work processes.
Serve as a technical resource for reference laboratory staff and external customers to assist with resolution of complex technical issues.
Perform review of serologic investigations to ensure completeness and adherence to ARC policies and procedures.
Responsible for compliance with standard operating procedures and interpretation of test results in accordance with applicable regulatory requirements.

Manager, IRL

Develop and write Standard Operating Procedures for manufacturing processes.
Manage all manufacturing operations including development of product specifications and planning of manufacturing schedule.
Provide technical support to end user customers, Hemo bioscience employees and distributor sales team.
Represent Hemo bioscience at local, regional and national conventions, trade shows and sales meetings. 
Train Hemo bioscience internal personnel in basic blood group serology.
Research and construct case studies to accompany proficiency testing samples.
Design and develop marketing materials in collaboration with key suppliers and using information gathered from customers.
Implement various R & D projects relating to new product development.

Operations Manager

Willis-Knighton Health System

Duties included ABO and Rh typing, antibody screens, antibody identification, crossmatch testing, DAT, Rhogam work-ups, and preparation of neonatal aliquots for transfusion.  Also responsible for preparation of monthly blood utilization reports, maintaining readiness for inspections by CAP and other regulatory agencies, preventative maintenance and quality control testing in the areas of Blood Bank and Serology.   

Responsible for instruction and demonstration of prenatal and neonatal immunohematology and serology testing to medical technology students.

Responsible for validation and correlation studies for implementation of Immucor Galileo Echo automated Blood Bank instrument for pretransfusion testing; including ABO and Rh typing, antibody screens and antibody identification.

Blood Bank Lead Technologist

Experienced Clinical Laboratory Scientist, Blood Bank Specialist and Product Marketer with diverse background, including hospital blood bank, academic health sciences center transfusion services, and immunohematology reference laboratory settings.

20+ years of Transfusion Medicine experience also includes immunohematology reagent manufacturing operations management, quality assurance, hospital services / product distribution logistics, and sales/marketing/technical support.

ISO 13485
21 CFR 630
21 CFR 600-680
21 CFR 820

Specialties: Blood Group Serology, Compatibility Testing, Staff Training and Development, Technical Instruction, Product Technical Support, Therapeutic Apheresis, SOP construction, Technical Writing, Medical Writing, Product Management

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