Jobs at Obsidian Therapeutics

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. 

• 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. 

• 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