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Director, GMP Quality
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our brand new facility in Bedford, MA to support our growth. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We’re looking for an individual with a strong background in Cell Therapy GMP manufacturing to contribute to building Obsidian’s Quality practice and team. In this role, you’ll work collaboratively with internal and external stakeholders on CMC (internal) and CDMO/CMO (external) teams to assure phase appropriate Quality systems and processes are implemented. As part of our Technical Development, Manufacturing, and Quality department, you’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program cytoTIL15 engineered to make TILs more effective for more patients.
This is a unique opportunity to be a contributor in a well-funded pre-clinical company with blue chip investors, field-leading advisors, best-in-class partners (BMS and Vertex), and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
- Partner with Sr. Director of Quality, Technical Development and Manufacturing, and Clinical Operations peers to strategically develop phase appropriate approach to quality assurance and quality assurance systems. This is initially an individual contributor role, with an expectation of future management responsibilities as the organization evolves and grows.
- Be responsible for lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs).
- Assure the company and 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.
- Conduct clinical product release activities for drug substance, drug product, and /or finished goods for all phases of development including review and approval of Master Batch Records along with executed batch records.
- Represent Obsidian QA on external CMOs’ project teams. Manage Quality to Quality relationship with CMOs, including periodic visits to CMOs, as required.
- Assist with establishing and tracking of Quality metrics.
- Effectively interact with external contract manufacturers and testing laboratories and an internal multidisciplinary team to support manufacturing, testing, and stability.
- Manage and address associated deviations, investigations, CAPAs, change controls, OOS, Material Review Boards, product complaints etc.
- Implement necessary Quality Agreements.
- Assist in preparing or reviewing CMC sections of regulatory submissions.
- Conduct audits of CMOs/ Testing Laboratories by overseeing vendor management.
- Provide QA support for regulatory inspections.
- Provide QA expertise in the development of Obsidian quality systems, processes, and procedures.
- Bachelor’s degree in biology, chemistry, engineering, life sciences or a related field.
- 10-+ years of direct Quality experience in a cGMP environment,8+ years in a Quality leadership role.
- Experience in the Cell Therapy space.
- Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations.
- A track record of good judgment in elevating issues and determining solutions and actions in high consequence situations.
- Demonstrated ability to recognize quality issues that will result in critical delays in schedule or operations and may jeopardize overall business activities.
- Highly collaborative working style – build trusting relationships, invite and share ideas and feedback, productively challenge own and others’ assumptions to generate new ideas and facilitate the better outcomes.
- Self-motivation and a proven ability to work with general direction to meet objectives and timelines.
- Flexibility, you readily adapt to changes and priorities in order to fulfill our mission.
- Strong technical writing and scientific skills
- Solid project management skills and experience managing complex projects.
- Ability to travel domestically and internationally as required (estimated 20%).
- Experience in analytical and process validations strongly preferred.
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.