Donald Macpherson Email & Phone Number

Seattle, Wa - Washington, Us

Remediation Projects. Assist in identifying and resolving compliance issues, provide impactassessment of quality deficiencies.

Berkeley, California, Us

Responsibilities included for Quality Assurance, Quality Control and Regulatory Affairs. As a start-up transitioning to manufacturing in collaboration with our CMOs, CDMO, and CLO’s. Provided strategic leadership and vision to help develop the quality journey.Responsible for all Quality Assurance, Quality Control and Regulatory operations, including Product Specifications, Supplier Approval/Raw Materials program, In-Process Testing, Analytical & Microbiological Testing, Product Safety, Final Batch Release, CAPA and Stability Testing. Coordinating QC Analytical/Microbial method development, transfer and validation.• Lead processes to improve product and supply quality and regulatory compliance.• Responsible for the CMO and CLO evaluation process – auditing and approval of potential partner sites.• Implemented and managed quality agreements with CMOs, CDMO, CLOs and warehouses.

As Regional Manager responsibilities covered overseeing the operation of the three enzyme quality control laboratories (Franklinton, NC: Blair, NE: Curitiba, Brazil). Member of the Global Quality Control Management Team. Provided strategic input on our mission, goals, improvement targets in order to meet the changing production demands. Translate these into actionable goals and targets for the regional laboratories. Utilizing Lean concepts in the laboratory operation with the goal of decoupling cost from growth, supplying results in the expected time frame and maintaining a safe and satisfying work environment. Provide strong internal and external customer focus.Senior Quality Control ManagerNovozymes N.A.Responsible for all laboratory operations at the Franklinton site: including performance, safety, quality and commitment to the GQC organization. Provide input for strategic vision, objectives, and goals for the Global Quality Control Organization. Drive local initiatives for laboratory improvement & provide Subject Matter Experts for the regional laboratories. Demonstrate a strong internal and external customer focus in all job responsibilities. Provide support, and quality overview for the Regional Quality Control Laboratories in the America’s

Instructor for Bio-Work Process Technician CourseCourse modules – Quality (GMP), Chemistry, Mathematics, Microbiology/Sterile processing & Fermentation modules. The course consists of 128 hours of instruction to prepare individuals to be employed as process technicians in the biotechnology industry.• Member of the Bioprocess Advisory committee for Vance Granville Community CollegeBio-Network Learning Center • Industrial Advisory Board member for the North Carolina Community College System.

Medical Device Manufacturer of biological products from bacterial, fungal, and animal sources.Responsible for fermentation operations, all in-house and custom fermentations. Compliance to all safety, BL3 containment measures, cGMP requirements, and review of all manufacturing documentation

St. Louis, Mo, Us

Responsible for the production of various bacterial (anaerobic & aerobic) organisms via fermentation. 5 direct reports.