Our Opportunity…

We are looking for a strategic and hands-on Associate Director, IT Operations to lead and optimize Digital Solutions & Technology operations at Obsidian, delivering secure, compliant, and scalable technology services that enable our clinical-stage biotech teams to achieve breakthrough scientific and business outcomes.

You Will...

• Develop and execute Digital Solutions & Technology operations strategy aligned with Obsidian’s growth, compliance needs, and culture. 
• Lead day-to-day operations, including infrastructure, cloud environments, enterprise systems, and lab/scientific software. 
• Manage MSP resources, ensuring high-quality support and service levels. 
• Partner with Info Security lead to ensure robust cybersecurity and data protection. 
• Optimize Digital Solutions & Technology processes (incident, problem, change management) and drive adoption of best practices, with a strong emphasis on ITIL and change management in a controlled, regulated environment. 
• Manage vendor relationships and operations budget. 
• Support onboarding/offboarding, access management, and end-user training. 
• Foster a culture of accountability, collaboration, and continuous improvement. 
• Risk Management & Business Continuity: Identify, assess, and mitigate IT risks; develop and maintain business continuity and disaster recovery plans. 
• Work closely with Facilities, Lab Operations, and other business units to ensure Digital Solutions meet evolving scientific and operational needs. 
• Continuous Improvement & Innovation: Drive process optimization and adoption of new technologies to improve service delivery and operational efficiency. 
• KPIs & Metrics: Define, track, and report on IT operational KPIs (e.g., uptime, ticket resolution, user satisfaction, compliance metrics). 
• Regulatory Audit Readiness: Prepare for and support regulatory audits (FDA, SOX, etc.), ensuring documentation and processes are audit-ready. 

Key Systems & Platforms 

• Networking: Cisco Meraki, Fortinet 
• Scientific/Lab: Benchling, Egnyte 
• HR: ADP, Greenhouse, Pave 
• Finance: NetSuite, FloQast, Concur 
• Business Development: DataSite DataRooms 
• Enterprise: M365, Adobe, Teams, Teams Room Systems 
• Ticketing: Freshdesk 
• Compliance: ComplianceWire, validated SharePoint 

 You Bring...

Core Qualifications

• Bachelor's degree in computer science, Information Technology, or related field with 10+ years of relevant IT experience, including leadership of IT operations in a regulated environment (biotech, pharma, or healthcare preferred). 
• Experience with IT operations in agile, fast-growing companies. 
• Experience with GxP systems operational support (CSV/CSA). 
• Experience with change control systems and processes for GxP/SOX. 
• Experience managing MSPs and IT service delivery across multiple locations. 
• Strong knowledge of enterprise platforms (NetSuite, M365, ADP, Benchling, etc.) and lab/scientific software. 
• Experience managing Lab IT systems 
• Excellent planning, coordination, and time management skills. 
• Strong oral, written, and visual communication skills. 
• Ability to build productive relationships across scientific, business, and technical teams. 
• Systems thinking and sound judgment, especially in risk management and escalation 
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes 
• Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.   
• Flexible - adapts to change in a fast paced, rapidly developing environment 
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner 
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments  

Our Opportunity...

We are looking for a highly motivated Director, Cell Orchestration and Logistics. As a key individual contributor within our Technical Operations team, you will oversee and coordinate the end to end product journey from patient starting material collection through final Investigational Product delivery, ensuring high reliability, cycle time performance, quality compliance, and cost effectiveness across Obsidian’s network of contract development and manufacturing organizations (CDMO’s), helping to drive the development of our first clinical stage autologous cell therapy program targeting solid tumors. 

Partnering closely with Clinical Operations, CMC, Regulatory, Quality, and external vendors, you will drive Cell Orchestration system implementation, CDMO slot scheduling as well as support activities including SOP management, deviation investigation, change management according to current good manufacturing practices (cGMP). This position requires an individual proven record of establishing strong partnerships internally and externally to manage a complex autologous engineered cell therapy manufacturing network and deliver transformative medicine to patients. 

You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by collaboratively translating innovative science into medical breakthroughs for patients starting with our lead program 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, innovative, passionate, collaborative, 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...

• Define and lead the overall Cell Orchestration governance system, including strategic and daily management oversight to ensure the highest level of service level for patients through cycle time optimization and network allocation. 
• Lead the implementation of a Cell Orchestration solution to support pivotal and commercial phases. 
• Coordinate and execute all logistics requirements across all GMP and non GMP material transfers 
• Oversee logistics partners’ performance with a focus on quality, reliability, and cost-effectiveness.  
• Develop and manage the department’s annual logistics budget based on program goals and enrollment plans; partner with Finance to analyze variances and implement adjustments.  
• Establish performance metrics, KPIs, and escalation pathways to ensure operational excellence and partner accountability 
• Support BLA-enabling supply chain activities, including Chain of Identify and Chain of Custody strategies, shipping validation and temperature monitoring strategies. 
• Proactively identify, assess, and mitigate operational, quality, and organizational risks; escalate key risks and issues. 
• Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability 
• Partner with Technical Operations & Quality, Regulatory and Finance to ensure full compliance with GxP, GMP, and other regulatory requirements. 
• Together with the VP, Global Supply Chain, identify opportunities to leverage AI capabilities of current systems in the near term, and a mid-to-long term strategy to leverage AI into cell orchestration and logistics as our programs advance. 

You Bring...

Core Qualifications

• Bachelor's degree in Supply Chain Management, Business, Engineering, or related discipline with 12+ years of progressive experience within the biopharma industry, including experience in cell & gene therapy. 
• Strong knowledge of and/or direct experience in autologous cell therapy focused on Patient Supply management. 
• Extensive quality and compliance background in a clinical GMP operational environment, including a minimum of 5+ years in a commercial or clinical GMP environment and 3 years prior experience in Cell and Gene Therapy Cold Chain Logistics.  
• Extensive experience in Cell Orchestration, supply chain planning, ERP system, capacity modeling, supply network strategy, and optimization. 
• Expertise and track record in manufacturing and supply chain execution and oversight. 
• Expertise on just in time logistics. 
• Solid knowledge of regulatory requirements, regulatory guidance, including pharmaceutical GMPs and ICH guidance. 
• 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...

• Strong knowledge of managing temperature controlled cold chains including 2-8C, -80C, and LN2 preferred; including prior experience in managing such shipments in collaboration with logistics partners.  
• Familiarity with AI-powered supply chain tools. 
• Ability to translate complex supply chain challenges into AI/ML use cases. 

Our Opportunity...

We are looking for a highly motivated Associate Director of Data Management. As a key contributor within the Clinical Operations team, you’ll be responsible for leading the entire data lifecycle at the program level for development of our first clinical stage autologous cell therapy program targeting solid tumors. 

You will be responsible from study startup to database lock for multiple clinical studies developing engineered TIL cell therapies for certain solid tumor indications, oversee end-to-end clinical data strategy, ensuring high-quality, regulatory-compliant data (e.g., SDTM/CDISC) from study startup to lock. 

You will be a vital part of a highly collaborative team working to achieve Obsidian’s vision by collaboratively translating innovative science into medical breakthroughs for patients starting with our lead program 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, 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. 

This is a Hybrid role based out of Bedford or Cambridge, MA locations.  

You Will...

Core responsibilities

• Manage all clinical data management (CDM) activities, serving as the primary point of contact for CROs and vendors, ensuring studies are delivered on time, within budget, and in compliance with ICH-GCP  
• Actively represent Data Management in study team meetings, leadership forums, and regulatory audits 
• Provide expertise in database setup, CRF design, and development of data management strategy to ensure high-quality, submission-ready data  
• Develop data management plans (DMPs) and provide technical guidance on clinical database structures to internal teams and external partners  
• Ensure all clinical data, including AE and SAE data, complies with CDISC standards (CDASH/SDTM) and is prepared for FDA and EMA submissions  
• Oversee data cleaning, discrepancy management, and reconciliation of third-party data sources (e.g., central labs, IRT)  
• Collaborate with Programming to implement internal data quality checks and support ongoing data review activities  
• Partner with Clinical Operations, Biostatistics, Medical Monitoring, and Regulatory Affairs to define data standards, assess data quality, and resolve queries  
• Ensure integration of data across clinical and manufacturing systems, including specialized tracking such as scalpel-to-vein processes for TIL therapy  
• Manage vendors and ensure appropriate resourcing to support clinical trial execution  
• Coordinate CDM deliverables across internal and external cross-functional teams  
• Collaborate with Supply Chain and Logistics to oversee tracking of manufacturing data  
• Work with Standards, Quality, and Compliance teams to develop and implement data standards and drive continuous process improvement  
• Develop and refine standard operating procedures (SOPs)  
• Apply strong project management, organizational, and interpersonal skills to support successful study execution 
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes  
• Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.    
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments 

You Bring...

Core Qualifications

• Education: Bachelor's Degree in life sciences, mathematics, or related field; with 10+ years of progressive experience in a biopharma setting, or a master's degree with 8+ (Master’s preferred). 
• Experience: 6 - 8+ years of experience in clinical data management, including significant experience in oncology, and ideally in cell therapy. 
• Systems: Proficiency in electronic data capture (EDC) systems, particularly Medidata Rave. 
• Technical Knowledge: Strong understanding of CDISC, SDTM, CDASH, and ICH-GCP regulations. 
• Leadership: Proven ability to manage CROs and lead cross-functional teams. 
• 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.   
• Ability to build and maintain productive relationships with colleagues within the clinical team, across the Obsidian organization, and with external partners.   

Our Opportunity… 

We’re looking for a highly motivated Associate Scientist with a background in viral vector analytical development to help drive the development of our cell therapy products. As member of our Technical Operations department 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 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, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

This is an onsite role located in our Bedford office. 

You will… 

• Learn and execute analytical methods to support characterization studies of Viral Vector starting materials and cell therapy products.
• Help design and execute experiments in collaboration with process development team to support critical material characterization.
• Author and review technical documents and data presentation including, but not limited to, study protocols, reports, and test methods.
• Maintain excellent records of experiments, including Electronic Notebook .
• Collaborate effectively across the Obsidian organization.
• Present internally to project teams, management, and scientific teams.
• Perform assigned work independently following established procedures with limited direction.

You bring… 

Core Qualifications 

• MS with 2+ or BS with 4+ years of relevant industry experience (degree in a relevant field such as biochemistry, cell biology, engineering, immunology).
• Excellent aseptic techniques and experience in product release and characterization methods with a focus on cell-based assays including cell-based titer assays, vector potency assays and molecular and immunoassays (PCR / qPCR, ddPCR, ELISA and MSD).
• Excellent organizational and documentation skills with the ability to communicate and prioritize effectively to deliver results within established timelines.
• Effective organization and record-keeping skills, including an ability to manage multiple responsibilities in parallel.
• Self-motivation and a proven ability to work autonomously with general direction to meet objectives and timelines.
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership. 
• Scientifically rigorous in designing and executing experiments, and record keeping.
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes
• Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.
• Flexible - adapts to change in a fast paced, rapidly developing environment
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments

Bonus Qualifications 

• Experience with multi-parameter flow cytometry assays
• Demonstrated track record with analytical development supporting late-stage development of cell therapies or biologics.
• Experience with analytical assay technical transfer and/ or qualification.
• Experience working in a QC laboratory