Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.

Agios Pharmaceuticals is searching for an energetic Senior Specialist, GMP Quality Assurance. This individual will have responsibility for lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional will assure the company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards, as well as regulations of applicable authorities.

Key Responsibilities

• Conduct product release activities for drug substances, intermediates, drug product and finished goods for all phases of development including review and approval of master batch records and executed batch records.
• Provide onsite oversight/monitoring of manufacturing campaigns as appropriate
• Coordinate QP release as appropriate
• Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition
• Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to conduct, review and approve manufacturing, testing, and product complaint investigations.
• Assist in preparing or reviewing CMC sections of regulatory submissions
• Manage and address associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.
• Implement necessary Quality Agreements
• Represent the QA department on project teams
• Conduct audits of CMOs and Testing Laboratories
• Both domestic and international travel will be required