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 Director/Senior Director, MSAT, with a strong background in drug development (preferably autologous cell therapy). You’ll serve as the go-to technical leader for manufacturing operations, solving complex problems and translating data into actionable improvements, helping to drive the development of our first clinical stage autologous cell therapy program targeting solid tumors.
You will lead end-to-end MSAT strategy and execution, ensuring seamless progression from late-stage development through PPQ and lifecycle management. As the primary technical anchor between Process Development, Manufacturing, Quality, and our external partners, you’ll ensure the manufacturing processes remain robust, compliant, and efficient; drive deviation investigations to root cause, monitor critical process parameters (CPPs) and critical quality attributes (CQAs), and perform data trending and statistical analysis.
As a member of our Technical Operations 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 out of our Bedford, MA location.
You Will...
Core responsibilities
- Serve as the lead MSAT interface to CDMOs, providing technical oversight of clinical manufacturing to ensure consistent production, rapid troubleshooting, and accelerated release of cell therapy drug product, viral vector drug substance, and custom biologic ancillary materials for patients in ongoing trials.
- Manage escalations through joint governance forums and collaborate with Process Development and External Manufacturing to align on technical decisions and execution.
- Define and maintain CPPs, CQAs with CDMOs
- Partner with Process Development and Analytical Development to define process characterization plans, comparability strategy, and lifecycle control approaches.
- Define and implement a comprehensive control strategy ahead of PPQ to enable consistent process performance, assure product quality, and support a successful validation and regulatory outcome
- Own and maintain the integrity of process monitoring databases (CPV, PPQ, and lot history), utilizing statistical tools to monitor process variability, analyze trends, detect shifts, quantify variation, identify signals requiring investigation, and drive data-based insights and decisions.
- Lead manufacturing campaign review processes.
- Define and lead PPQ strategy and execution, ensuring timely and comprehensive PPQ readiness.
- Oversee authoring and review of batch records, validation protocols, and validation/verification reports.
- Ensure documentation is scientifically rigorous, operationally usable, phase-appropriate, and compliant.
- Drive governance of tech transfer plans, protocols, and reports; and process validation documentation.
- Structure the MSAT team’s technical materials for BLA readiness, ensuring lifecycle validation documentation is pristine.
- Author and/or review relevant CMC sections of regulatory submissions, including the compilation and lock of all scientifically rigorous MSAT reports and relevant data packages. Ensure the technical dossier is fully complete and ready for BLA submission.
- Serve as MSAT subject matter expert in support of FDA interactions, inspection readiness, and PAI execution.
- Serve as the technical lead in complex or consequential process-related manufacturing investigations/deviations, change controls, complaints, and CAPAs. Partner with External Manufacturing and Quality to ensure consistent investigation standards and timely, effective remediation across CDMO and internal teams.
- Provide technical leadership for risk management, including facilitating and documenting SIPOC, FMEA, and/or HAZOP to define controls, reduce variability, and mitigate risks.
- Prepare CDMOs and internal teams for PAI, ensuring audit readiness with complete documentation and lifecycle validation materials.
- Align team priorities and focus with company strategy and goals.
- Drive a team culture of high standards, collaboration, transparency, accountability, continuous learning, and trust.
You Bring...
Core Qualifications
- MS/PhD in Chemical Engineering, Bioengineering, Biology, or related field with 10+ Years of experience (12+Senior Director), or equivalent combination of education and experience.
- 5 years successfully leading late stage and/or commercial MSAT team for a novel therapy in an external manufacturing model.
- Autologous cell therapy experience.
- A data driven and detail-oriented mindset, with the ability to drive timely fact-based cross functional analysis and decision making in complex and high consequence scenarios.
- Knowledge of FDA guidance relevant to cell and gene therapy manufacturing, validation, and lifecycle management (EMA is a plus).
- Strong experience in:
- Leading and documenting risk assessments (e.g., SIPOC, FMEA, and/or HAZOP) and root cause analysis methods (e.g., 5-Why, Fishbone/Ishikawa)
- Analyzing and interpreting manufacturing/process data using statistical tools (e.g., JMP or Minitab) to support trending, investigations, and continuous improvement
- Process validation (PPQ), CPV, and regulatory submissions
- BLA/MAA support and inspection readiness
- cGMP requirements applied to autologous cell therapy manufacturing
- Client-side oversight of CDMO operations
- Proven ability to thrive as a leader in a fast-paced dynamic environment, successfully building, motivating, developing, and retaining high performing teams.
- Willingness and ability to travel domestically up to ~30% for on-site CDMO support, including after-hours/weekend coverage when needed to support critical activities.
- 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
- Prior experience working with TIL or T cells
- Support of first commercial launch
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.
