Obsidian Therapeutics
Biotech
Director,ManufacturingScienceandTechnology(MSAT)
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“Director, Manufacturing Science and Technology (MSAT) at Obsidian Therapeutics. Skills: MSAT strategy and execution, Process Development, Manufacturing, Quality, CDMO oversight, Process validation, Regulatory submissions. 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 ”
What You'll Achieve.
deliver transformative outcomes for patients
Industry & Context.
system design; risk management; SIPOC; FMEA; HAZOP; 5-Why; Fishbone/Ishikawa
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.
What They're Looking For.
Must Have
PhD, MS, or BS in Chemical Engineering, Bioengineering, Biology, or related field. 15+ years of progressive experience, including at least 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). 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.
What You'll Do.
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 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.
How You'll Work.
Team & Collaboration
Cultivates collaboration, transparency, and accountability within and across recognizes success requires interdisciplinary thinking and partnership. Inspires confidence, credibility, and trust internally and recognized for high integrity.
Communication Scope
Exceptional communication skills in verbal, written, and visual formats, and adapted to the audience
Full 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 are looking for a highly motivated 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. You’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating inn
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