Senior Manager/Associate Director, External Manufacturing

About this role

About Us …

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® 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 clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.

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 Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity...

We are looking for a highly motivated Senior Manager/Associate Director External Manufacturing, with a strong background in CDMO management of viral vector and ancillary materials production. As a key contributor within the External Manufacturing organization, you’ll lead front-line oversight of viral vector and ancillary material production, helping to drive the development of our first autologous cell therapy program targeting solid tumors In addition, you’ll establish a new phase appropriate manufacturing specialist function that will be responsible for deviation management, change control, MBRs, and continuous improvement across the manufacturing network.

You’ll be responsible for the manufacturing value stream, including adherence to production scheduling, CDMO training, site PIP management, CDMO operational performance, triage and management of investigations, batch record revisions, change controls, continuous improvement, CDMO operational readiness, financial reporting and budget adherence.

As a member of our Technical Operations team, you will 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 Amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.

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, collaborative, innovative, passionate, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

This is a Hybrid role based out of our Bedford, MA location.

You Will...

Core responsibilities

• Deeply understand Obsidian’s viral vector, ancillary material and autologous cell therapy DP manufacturing processes to ensure exceptional manufacturing success rates, product consistency, and on-time delivery.

• Oversee execution of viral vector and ancillary drug substance manufacturing across a network of CDMO partners to ensure supply chain continuity and high-quality supply to the clinic

• Manage or collaborate on critical CDMO investigations, technical batch record review, MBR/ EBR revisions, change controls and continuous improvement projects as needed to enable exceptional manufacturing success rate, on time production and lot disposition.

• Oversee CDMO performance metrics for manufacturing and internal stakeholders, driving understanding of operational strengths, outcomes of strategic initiatives e and continuous improvement opportunities

• Ensure ongoing operational readiness at CDMOs with a focus on operator training, suite/ equipment readiness, solution preparation and on the floor materials management.

• Contribute to cost-of-goods (COGS) optimization and value creation by leading continuous improvement initiatives with CDMO partners, including system/ process optimization, improvement of success rates, deviation generation rates and ways of working

• Participate in strategic sourcing, vendor selection, capacity planning, SOW/ forecast review, and ongoing supplier relationship management for key services

• Partner closely with QA, MS&T, QC, CMC Project Management and Supply Chain to ensure systems are fit for purpose for program phase.

• Coach CDMOs on phase appropriate standards for operations, including scheduling, operational performance metrics, batch release, equipment maintenance, and financial reporting

• Foster a high-performance culture with CDMO partners and internally.

• Enable team success and individual growth through clear expectations, high standards/support, stretch assignments, and coaching.

You Bring...

Core Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or related discipline with; Senior Manager 8+ (MS 6+), Associate Director 10+ (MS 8+) years of experience in manufacturing or MS&T roles in the biotech/pharma industry.

• Demonstrated success leading outsourced manufacturing operations across a network of CDMOs, including technology transfers, late-stage clinical/ commercial production, issue/ change management and continuous improvement, preferably in cell and gene therapy or other complex biologic modalities.

• Extensive experience designing and implementing batch records, EBRs, and MES integrated systems

• Deep experience in quality systems, deviation management, root cause analysis, change control, and risk management in a GMP environment.

• Proven application of Lean manufacturing and operational excellence tools and techniques to improve manufacturing cycle times and right first-time execution.

• Strong understanding of GMP regulations, quality requirements, and global regulatory expectations for advanced therapies

• Proficiency in developing and managing SOWs, change orders, contract negotiations, CDMO budget planning, financial reporting, and budget management

• Demonstrated ability to

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