Senior Manager/Associate Director, External Manufacturing

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 initiativese 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 lead cross-functional teams to achieve ambitious goals, manage complex projects, and influence at all levels of the organization
• Ability to travel 25-30% of time
• Excellent planning, coordination, and time management skills 
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership. 
• A desire and ability to work in a dynamic, collaborative environment; building productive and healthy relationships within and across functions
• Cultivates collaboration, transparency, and accountability within and across teams; recognizes success requires interdisciplinary thinking and partnership.
• Inspires confidence, credibility, and trust internally and externally; recognized for high integrity.
• Operates with Urgency, adept at building buy-in and driving alignment within and across teams, senior leadership, and external partners. 
• Exceptional communication skills in verbal, written, and visual formats, and adapted to the audience. 
• Tenacious and resilient – has navigated significant challenges (scientific and business) and is not easily daunted. 
• Excellent organizational skills; able to manage multiple tasks of varying degrees of complexity in parallel. 
• Remains calm under pressure and leads others through complex situations. 
• Seeks the data, information, and support needed (internally and externally) to make efficient and informed decisions and meet objectives.  
• Builds followership by being transparent, persuasive, excited about the work, and willing to work hard together to get the job done. 
• Continuous learner – actively follows innovations in area of expertise, fosters innovative thinking, and adopts novel approaches that are fit for purpose.
• Reflective and self-aware; leads by example with a growth mindset.

Bonus Qualifications

• Experience leading internal manufacturing teams for cell and gene therapy
• Experience with tech transfer and GMP production of fill/ finish processes
• Experience with cell therapy commercialization internally or at a CDMO