Senior Director, External Manufacturing

Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. We are investigating OBX-115 and enrolling patients in an ongoing multicenter clinical trial in advanced melanoma and non-small cell lung cancer (Agni-01). We’re proud of our diverse talented team and committed to cultivating an environment 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 facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

This position is responsible for leading the oversight of Obsidian's network of contract development and manufacturing organizations (CDMOs) inclusive of cell therapy drug substance/drug product and viral vector drug substance production for both clinical phase and commercial phase products. Reporting to the head of Technical Operations, the Manufacturing Head provides the leadership, strategic thinking, and results focus to reliably meet and/or exceed the company's manufacturing goals while maintaining high levels of quality.

Partnering with internal and external stakeholders, you will drive direct production activities as well as support activities including batch record/SOP management, production scheduling, deviation investigations, change management, and training all according to current good manufacturing practices (cGMP). This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, 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.

We are open to either a hybrid (Bedford, MA) or remote (greater Philadelphia, PA area) work location; with 30-40% of time on site at our CDMO.

Responsibilities

• Define and lead overall governance system for CDMOs from strategic to daily management oversight ensuring processes and practices are compliant with global current good manufacturing practices.
• Partner with technical teams and program management to facilitate technical transfer of processes to new CDMOs including development and revision of batch records and procedures, management of change controls, and establishing comprehensive process and equipment training programs.
• Review and/or author technical and project protocols and plans and reports in support of technical studies, stage gate reviews, and global regulatory filings.
• Acting as virtual Plant Manager and value stream team leader, partner with MS&T, QC/QA, and Supply Chain to oversee external production of clinical and commercial cell therapy products and ensure timely disposition of product.
• Develop and build a high performing manufacturing team to execute department responsibilities and achieve corporate and department objectives.
• Ensure effective engagement, integrated and collaborative execution, and robust development.
• Establish department, CDMO, and individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics and partner with Supply Chain and Quality to conduct periodic business reviews with each CDMO.
• Drive continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Develop and manage department’s annual operating budgets; partner with Finance to analyze variances and implement adjustments.
• Proactively identify, assess, and mitigate operational, quality, and organizational risks escalate key risks and issues.

Core Qualifications

• Bachelor's degree and 15+ years of related biopharmaceutical work experience or a Master’s degree and 12+ years of work experience.
• 8+ years in management/leadership positions of increasing scope and responsibility.
• Minimum of 5 years successfully leading late stage and/or commercial cGMP operations team in fast-paced internal and/or external manufacturing environments.
• Experience in cell and/or gene therapy operations (strong preference).
• Strong analytical and strategic problem-solving skills; great attention to detail and the ability to drive timely and fact-based cross functional decision making in complex, high consequence scenarios.
• Excellent written and oral communication skills both internal and external.
• Proven ability to thrive as a leader in a complex and fast-paced dynamic environment, successfully building, motivating, developing, and retaining high performing teams.
• A leadership approach that inspires confidence, credibility, and trust internally (within and across teams) and you’re adept at inviting different perspectives, resolving issues in a constructive manner, facilitating data-based decision making, and building buy-in.
• Exceptional organizational skills and record of delivering results, including robust risk management and transparent communications.
• Ability to gown and navigate cGMP manufacturing areas.
• An ability to be on-site at CDMO up to 30-40% of time (for day trips, the ideal location is mid-Atlantic; if based in Boston area travel of this amount will be required).
• Preference for experience in start-up of new manufacturing capabilities/capacity.

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.