--- title: 'Associate Director/Director, CMC Digital Business Partner at Obsidian Therapeutics' canonical: 'https://feeny.ai/job/associate-director-director-cmc-digital-business-partner-obsidian-therapeutics-4cdv9q5wppt8' type: 'job' last_seen: '2026-10-31' --- # Associate Director/Director, CMC Digital Business Partner at Obsidian Therapeutics - **Company:** Obsidian Therapeutics - **Location:** Bedford, MA - **Compensation:** $176k–$252k - **Work type:** hybrid - **Posted:** 2026-10-19 - **Last confirmed live:** 2026-10-31 - **Apply:** https://job-boards.greenhouse.io/obsidiantherapeutics/jobs/6227081004 ## Job description ## 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’re seeking an Associate Director/Director, CMC Digital Business Partner, to work closely with Technical Operations leadership to define, deliver, and maintain the digital systems needed to support and enable Obsidian’s GMP operations strategy.  In this role, you will partner with the Tech Ops/CMC business systems owners to translate business needs into inspection-ready digital capabilities aligned to the business’ priorities and milestones (including BLA readiness and commercial launch) and approved budget. Near term priorities include cell orchestration (chain of identity and custody), process data history and analytics, eQMS/document control, and ERP integration. In partnership with business system owners, you will select, implement, validate, integrate, support, and continuously improve key CMC digital platforms across internal and external operations through direct execution and engagement and oversight of consultants, systems integrators, and managed-service partners where warranted. The successful candidate will be highly collaborative and committed to understanding how the business runs in the internal processing suites, analytical labs, and partner interfaces. As a member of our Digital Solutions & Technology team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well-funded clinical company with field-leading advisors, best-in-class partners, and an experienced team. This is a hybrid role based in Bedford, MA, with periodic travel to CDMO and/or partner sites as needed. You Will... Core responsibilities - Serve as the embedded digital business partner for Tech Ops/CMC, building trusted relationships with Manufacturing, MSAT/Process Development, Analytical Development, Quality, Supply Chain, CMC Regulatory, Facilities, CMC Program Management and external partners as needed. - Partner with Tech Ops/CMC leadership to develop and deliver the CMC digital strategy, roadmap, and systems portfolio, serving as Technical System Owner for platforms supporting manufacturing execution, cell orchestration/COI-COC, laboratory informatics, logistics/ distribution, quality operations, and ERP integration; aligned with BLA and commercial launch readiness. - Translate CMC business needs into aligned, prioritized, and delivered digital capabilities — balancing business value, compliance, funding, timing, and technical complexity, and communicating options and tradeoffs clearly to both Tech Ops and Digital leadership. - Lead technical delivery of GxP systems personally and through partners, including business case, requirements, vendor selection, solution architecture, configuration, integration, data migration, validation, deployment, hyper care, support, and ongoing lifecycle management. - Define and build the CMC data architecture and digital interfaces across manufacturing, quality, laboratory, logistics, facilities/engineering, CDMO, and ERP data through governed master data, high value digital integrations, contextualized data models, and self-service analytics that support process monitoring, CPV, investigations, product disposition / release, and APR while maintaining high levels of compliance, data privacy and security. - Partner with CMC project management to define and establish a CMC digital system governance framework for the identification, prioritization, and activation of all CMC digital projects on time to meet Obsidian’s overall program and strategy requirements. - Partner with Quality to improve and align Obsidian’s GXP computer system lifecycle QMS processes and practices with industry best practices for late stage / commercial cell and gene therapies including establish and maintain fit-for-purpose CSV/CSA and data integrity practices, including GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, audit trail review, periodic review, change control, and inspection/audit support for CMC digital systems. - Partner with Information Security, Digital Infrastructure, and Facilities to deliver secure, scalable CMC capabilities. - Oversee the CMC digital portfolio, including financial management, vendor relationships, contracts, and service delivery through a lean operating model. You Bring... Core Qualifications - Bachelor's degree in computer science, Engineering, Information Systems, Life Sciences, or a related field, with 10+ years of IT/digital experience in the biotech/pharmaceutical industry, including significant time owning manufacturing or laboratory systems end to end. - Demonstrated ownership of GxP manufacturing and laboratory systems in a regulated cell therapy, gene therapy, or complex biologics environment — with hands-on accountability for at least two of: MES/eBR, LIMS/ELN, cell orchestration (COI/COC), or process data historian/analytics. - Proven success as an embedded business partner to a manufacturing/technical operations organization — with concrete examples of building credibility with Manufacturing, MSAT, and Quality leaders from a standing start, participating in planning and decisions early, and influencing senior stakeholders without direct authority. - Experience supporting CDMO/CMO external manufacturing or internal (in-house) manufacturing — including establishing data exchange, batch record and QC data transfer, system connectivity, and oversight of partner-executed operations. - Deep working knowledge of GxP compliance for computerized systems: 21 CFR Part 11, EU Annex 11, GAMP 5 / CSV and CSA-based validation, data integrity (ALCOA+), change control, and supporting regulatory inspections or partner audits. - Track record delivering full-lifecycle system implementations — from business case and vendor selection through validation, go-live, and sustained support — on schedule and on budget. - Comfortable operating as a hands-on individual contributor in a small, maturing company environment: personally writing requirements, configuring or testing, and delivering through vendors, consultants, and integrators rather than a large internal team. - Experience with systems supporting shipping/logistics and cold chain for temperature-sensitive or cryopreserved material, including courier/3PL integration and chain-of-custody traceability. - Strong systems integration and data architecture fluency: APIs/middleware, ISA-95 concepts, master data management, and integration of manufacturing systems with ERP, eQMS, and analytics platforms. - Genuine operational curiosity; fluent enough in the process and the science to hold a peer-level conversation with scientists and manufacturing leads, and disciplined about understanding a workflow before proposing to digitize it. - Successful experience managing vendors, contracts, budgets, and systems integrators or managed-service partners. - Excellent written and verbal communication skills, with the ability to translate between technical and operational/scientific audiences. - 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 - Autologous cell therapy experience, including vein-to-vein scheduling, apheresis and infusion site coordination, and patient/COI-linked manufacturing. - Experience standing up CMC digital capability in a late stage / commercial company including first-time (greenfield) deployments. - Hands-on experience with specific platforms such as TrakCel/, SAP Advanced Therapy Orchestration, Apprentice, Benchling, Veeva Vault QMS/QualityDocs, MasterControl and Process Data Analytics Tools such as Skyland PIMS - Familiarity with eQMS, controlled document management, and training/LMS platforms, and with facilities/engineering systems (BMS, environmental monitoring, CMMS, calibration). - Cloud, data engineering, or advanced analytics/AI experience applied to process data (e.g., multivariate analysis, CPV, predictive monitoring, digital twin concepts). – NMB: Hands on, ie. Separate it from via vendor - Experience with serialization, labeling, or track-and-trace systems, and with clinical supply/IRT interfaces to manufacturing. - Familiarity with OT/IT security frameworks and shop-floor network segmentation. - Formal project/program management or Agile certification (PMP, SAFe) or Lean/Six Sigma training. Obsidian is committed to equitable and transparent pay practices. The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location. Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities. Anticipated Base Salary Range $175,500—$251,500 USD 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. ## About Obsidian Therapeutics ## Company Overview - **One-liner**: Obsidian Therapeutics is a biotechnology company pioneering engineered tumor‑infiltrating lymphocyte (TIL) therapies for solid tumors using its proprietary cytoDRiVE® platform to regulate protein expression with an FDA‑approved small molecule. - **Entity Type**: Private (later‑stage; most recent Series C closed April 2024; entered a merger agreement with Galera Therapeutics and a concurrent $350M private placement announced in 2025) - **Headquarters**: Cambridge, Massachusetts, United States (with a laboratory facility in Bedford, MA) - **Founded**: 2015 - **Founders**: Not publicly disclosed on the company website; the leadership team includes a CEO, CTO, CMO, CFO, and Chief People Officer. ## Core Business - **Primary industry**: Biotechnology (cell and gene therapy, oncology) - **Target customers**: B2B / healthcare – primarily developing therapies for patients with solid tumors; partners with academic centers, clinical sites, and biopharma companies. - **Mission / purpose statement**: “Pioneering engineered cell and gene therapies to deliver transformative outcomes for patients.” The company emphasizes urgency for patients and a commitment to safer, more effective TIL therapies. ## Products & Services - **cytoDRiVE® Platform**: A proprietary technology that uses drug‑responsive domains (DRDs) to control the function of therapeutic proteins inside cells using an FDA‑approved small‑molecule ligand. The platform can be applied to membrane‑bound, intracellular, or secreted proteins. - **OBX‑115 (cytoTIL15)**: Lead clinical‑stage engineered TIL cell therapy that expresses membrane‑bound IL‑15 (mbIL15) to enhance TIL persistence and activity without the need for co‑administered IL‑2. Currently in Phase 1 trials for metastatic melanoma and non‑small cell lung cancer (NSCLC). (ClinicalTrials.gov identifiers: NCT05470283, NCT06060613) - **Pipeline**: Early‑stage research exploring OBX‑115 in combination with PD‑1 inhibitors, as well as additional undisclosed cytoTIL programs for other solid tumor indications. ## Market Standing - **Valuation / Market Cap**: Not disclosed (privately held). - **Key Metric – Total Funding**: $325 M in known equity rounds (Series A: $49.5 M led by Google Ventures, 2017; Series B: $115 M led by The Column Group, 2021; Series C: $160.5 M led by Wellington Management, 2024). Additionally, a $350 M private placement was announced in connection with a merger agreement with Galera Therapeutics (the transaction is ongoing). - **Notable Investors / Partners**: The Column Group, Wellington Management, Google Ventures (GV), and 14 other investors across rounds. - **Growth Signals**: Lead program OBX‑115 has completed enrollment in a single‑center melanoma study and is now enrolling in a multi‑center Phase 1 study (Agni‑01) for melanoma and NSCLC. The company acquired Galera Therapeutics and secured significant additional capital via a concurrent private placement, indicating strong investor confidence. Headcount as of mid‑2025 is ~92 employees, with a recent slight decline (-11.7% YoY) typical of a focused R‑stage biotech. Active job postings increased 100% month‑over‑month, suggesting renewed hiring. ## Competitive Advantages - **cytoDRiVE® Platform**: Provides tunable, on‑demand control of therapeutic proteins using an approved small molecule – a unique differentiator that can improve safety and efficacy in cell therapy. - **Focus on TIL therapy**: Targets the challenging solid tumor space where conventional TIL therapy is limited by IL‑2 toxicity. OBX‑115 removes the need for high‑dose IL‑2, potentially broadening patient access. - **Proprietary DRD library**: A growing, internally discovered set of drug‑responsive domains that enable rapid optimization for different cell types and protein classes. - **Well‑funded and experienced team**: Backed by top‑tier investors and led by executives with deep cell therapy and oncology expertise. ## Strategic Focus - **Clinical execution**: Advancing OBX‑115 through Phase 1 trials in melanoma and NSCLC, with plans to expand indications and combinations. - **Platform expansion**: Applying cytoDRiVE® to other cell and gene therapy modalities (e.g., CAR‑T, TCR, gene editing) through partnerships and internal programs. - **Manufacturing and scaling**: Building internal capabilities in process development, quality control, and supply chain to support commercial‑scale production. - **Talent growth**: Active hiring across R&D, quality, manufacturing, and IT (8 open positions at time of data pull), with a focus on hybrid roles in Cambridge and Bedford, MA. ## Why Work Here - **Culture**: The company describes itself as collaborative, curious, and authentic, with a strong sense of urgency to deliver therapies to patients. Emphasis on “no silos or hierarchies” and mutual respect. - **Work model**: Hybrid (Cambridge, MA and Bedford, MA). Some roles may offer remote flexibility; most job postings specify hybrid. - **Notable benefits**: - Employee stock options, 401(k) with HSA options. - Flexible time off (unlimited PTO policy). - 6 weeks fully paid bonding leave for new parents, plus fully paid medical maternity leave. - Generous health/dental coverage with low out‑of‑pocket costs and an annual HSA contribution. - Perks: gym, massage therapy, and meditation reimbursements; company‑sponsored lunches and social events. - Professional development: mentorship, training programs, tuition reimbursement, and career matrices for planning growth. - **Engineering / science culture**: Strong cross‑functional collaboration between research, process development, quality, and clinical teams. The company values diversity and inclusion and reports gender pay equity. ## Sources 1. [obsidiantx.com](https://obsidiantx.com/) – Company overview, platform, pipeline, and career page 2. [obsidiantx.com/about-us](https://obsidiantx.com/about-us/) – About Us, management team, vision 3. [obsidiantx.com/join-our-team](https://obsidiantx.com/join-our-team/) – Culture, benefits, open positions 4. [linkedin.com/company/obsidian-therapeutics](https://www.linkedin.com/company/obsidian-therapeutics) – Employee count, funding, headcount trends, recent departures 5. [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05470283) – OBX-115 melanoma study 6. [clinicaltrials.gov](https://classic.clinicaltrials.gov/ct2/show/NCT06060613) – OBX-115 Agni-01 study ## Other roles at Obsidian Therapeutics - [Senior Accountant](https://feeny.ai/job/senior-accountant-obsidian-therapeutics-cambridge-gwkghzks8bhb) — Cambridge, MA - [Research Associate (Contractor), Viral Vector Engineering and Production](https://feeny.ai/job/research-associate-contractor-viral-vector-engineering-and-production-obsidian-9ca0m445r120) — Cambridge, MA - [Research Associate (Contractor), Cell Therapy](https://feeny.ai/job/research-associate-contractor-cell-therapy-obsidian-therapeutics-cambridge-r20zjdh1a4h5) — Cambridge, MA - [Associate Director, Process Data Analytics](https://feeny.ai/job/associate-director-process-data-analytics-obsidian-therapeutics-bedford-3b2cq0sbv19z) — Bedford, MA - [Clinical Trial Coordinator](https://feeny.ai/job/clinical-trial-coordinator-obsidian-therapeutics-bedford-vvsrfj5z90xd) — Bedford, MA - [Scientist/Senior Scientist, Viral Vector Analytical Development](https://feeny.ai/job/scientist-senior-scientist-viral-vector-analytical-development-obsidian-vq7apj9r469n) — Bedford, MA - [General Interest Application - Obsidian Talent Community](https://feeny.ai/job/general-interest-application-obsidian-talent-community-obsidian-therapeutics-r3k8fnqhwtmp) — Cambridge, MA