Zach Isaacson

Directed the successful launch of an inaugural APS campaign, establishing a foundation for scalable operations. Led the team through operational readiness initiatives, including SOP development and facility validation.

Supported greenfield construction review and manufacturing build-out, implementing EBR systems and designing compliant manufacturing processes. Drafted procedures, URS documents, and conceptual renderings for process innovation.

Led the Quality Assurance team across commercial and allergy manufacturing lines, serving as a Subject Matter Expert during FDA and client audits. Managed facility internal audits and produced risk reports for quality leadership.

Ensured GMP and GDP compliance across aseptic fill/finish operations, investigating deviations and guiding corrective actions to maintain quality standards. Promoted collaboration and trust between manufacturing and QA departments.

Operated machinery and performed tasks as an Operator. Gained foundational experience in a manufacturing environment.

Performed duties as a Mechanical Laborer, gaining experience in industrial settings. Developed practical skills in equipment maintenance and operational support.

Worked as a Manufacturing Specialist, contributing to production processes. Developed expertise in pharmaceutical manufacturing operations.

Currently pursuing a Bachelor of Science in Business Administration with a focus on Management. This program is enhancing my strategic leadership and operational management skills.

Completed coursework in General Studies, providing a foundational academic background. This period of study contributed to a broad understanding of various subjects.