Agios (agios.com) is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases. We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform. We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities. We continue to foster a productive research engine that yields new insights and potential therapeutic approaches. We’re a company that cares about our work, each other, and the people who are counting on us the most. We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results. We’re driven to be our best selves, together, so we can reach for the Other Side of Possible
We are currently seeking a Manager/Sr. Manager, GMP Quality Assurance – Clinical. This individual will be responsible for supporting and maintaining high quality levels on Agios Drug Substance, Drug Product, packaged Drug Products and finished goods by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional must possess strong leadership skills in order to provide support to the QA Clinical team, and 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. Reporting to the Associate Director, GMP Quality Assurance and be a member of the GMP clinical group, this individual will have further responsibility to:
- 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
- Organize and coordinate QA operational packaging and labeling resources and schedule. Work collaboratively with key stakeholders on drug packaging/labeling strategies and plans to ensure investigational product releases within timelines.
- Effectively interact with external contract packagers/labelers and ID testing laboratories as well as work as part of an internal multidisciplinary team to support packaging/labeling, testing, and product complaint investigations.
- 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 (10%)
- Bachelor’s degree in biology, chemistry, life sciences or a related field; advanced degree preferred.
- Manager: 8-10 years’ experience of Quality Assurance experience in a cGMP manufacturing environment. Experience related to global clinical packaging and labeling is a plus.
- Senior Manager: 10+ years’ experience of Quality Assurance experience in a cGMP manufacturing environment. Experience related to global clinical packaging and labeling is a plus.
- Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations
- Exercises judgment within broadly defined practices and policies in determining solutions and actions
- Demonstrates ability to identify and recognize critical decisions that will result in critical delays in schedule or operations and may jeopardize overall business activities
- Knowledge of drug substance, drug product and solid dosage manufacturing principles, equipment and processes.
- Experience in drug substance and drug product manufacturing is required