The Senior Specialist, Product Disposition will support the timely and compliant disposition of Gene Therapy products across all stages of manufacturing. This role will assist in the review of batch documentation, coordination with internal and external stakeholders, and execution of quality system transactions in Oracle. The Senior Specialist will bring strong attention to detail, a quality-first mindset, and the ability to work cross-functionally in a fast-paced, regulated environment.
This position is considered a CORE role and will require consistent on-site presence. It will support the Gene Therapy Manufacturing Therapy (GTMF) location in Bedford, MA.
Responsibilities:
· Perform detailed review of all batch documentation for investigational and commercial products.
· Support the disposition process for cell banks, viral banks, plasmids, drug substance, drug product, and finished goods.
· Assist with the coordination of QP batch certification activities, including documentation preparation and response to QP queries.
· Execute and maintain Quality Management transactions in Oracle to support product release.
· Support the development and maintenance of the Product Specification File (PSF).
· Collaborate with cross-functional teams including Quality Control, Supply Chain, Regulatory Affairs, and Technical Operations.
· Escalate quality issues and risks to management in a timely manner.
· Support other QA systems and business processes as needed.
Requirements:
· Minimum of a Bachelor’s Degree in a science, engineering, or related discipline.
· 5+ years’ experience in a GxP-regulated pharmaceutical or biotechnology environment.
· Experience with product disposition, batch record review, or QA operations preferred.
· Familiarity with cGMP regulations and quality systems (US/EU).
· Experience with Oracle or similar ERP systems is highly desirable.
· Strong organizational, communication, and problem-solving skills.
· Ability to work independently and manage multiple priorities in a fast-paced environment.
· Experience with Veeva eQMS is a plus.