Associate Director, Quality Control

Associate Director, Quality Control

Bedford, MA

About Us…

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.

Our Opportunity… 

We’re looking for a scientist with a strong background in Quality Control and Assay Validation for cell and gene therapy programs to contribute to Obsidian’s external manufacturing oversight team where you’ll be a vital part of a highly collaborative individuals working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for 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.

You Will… 

• Liaise with internal teams and CDMOs during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns to develop and improve assays.
• Manage the Quality Control testing execution at multiple contract sites, ensuring laboratory processes provide high quality analytical support for lot disposition and stability.
• Generate internal and external documents such as quality control technical documents (method transfer, feasibility), validation and verification protocols, reports, sample forms, specifications, certificates of analysis, and SOPs.
• Provide QC representation to project team meetings. Relay pertinent information such as production schedules and information requests to project team members.
• Ensure that analytical activities, including method establishment, testing execution, method monitoring, and data reporting are performed according to agreed upon timelines in support of business objectives.
• In concert with Quality Assurance, oversee Quality Control requirements for compliance with cGMP/CFR/ICH/ regulations and guidelines, FDA and EMA guidance for cell and gene therapy products, and ISO/USP standards at external contract manufacturing and testing organizations.
• Work closely with Manufacturing and Quality Assurance staff to resolve quality issues regarding product manufacture.
• Be responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.
• Work in cooperation with Analytical Development, Quality Assurance and CDMO to design phase appropriate assay qualification, and validation protocols.
• Perform QC assessment of new raw materials required to support GMP manufacturing and testing.

You Bring… 

Core Qualifications

• Bachelor’s degree (MS preferred) in Life Sciences or related discipline with 8+ years of experience working in a bio-pharmaceutical Quality Control role in the Cell Therapy space.
• Experience with assays including but not limited to flow cytometry, cell counting, cytokine detection, ddPCR, cell-based potency assays, and VCN.
• Quality and compliance background in a clinical GMP operational environment (ideally including phase 1 and 2).
• Results-driven individual who is self-motivated while maintaining adherence to GMP compliance. 
• 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, adapt to changes and priorities in order to fulfill our mission.
• Confidence and good judgement to elevate relevant issues to project lead and line management.
• Strong technical writing and scientific skills.
• Solid project management skills and experience managing complex projects.
• Excellent communication skills.
• Scientific curiosity, and a track record of self-directed learning.
• Ability to travel up to 33% of time.

 Bonus Qualifications

• Prior experience working at or overseeing work completed at a CDMO/CMO.
• Prior experience with PPQ (process validation).
• While experience with cell therapy is a requirement, experience with T cells and TILs is a bonus.
• Experience with rapid release of autologous cell therapy products.
• Experience with gene therapy, including retroviral or lentiviral vectors.
• Prior experience with Tech Transfer of Analytical Methods to a CDMO/CMO.
• Quality and compliance background in a commercial GMP operational environment. 

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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.