Obsidian Therapeutics · 13 hours ago
Senior Director, External Manufacturing
Bedford, MA
Full-time
Hybrid
Director/Executive
15+ years expObsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. The Senior Director of External Manufacturing is responsible for leading the oversight of Obsidian's contract development and manufacturing organizations, ensuring compliance with good manufacturing practices and driving production activities to meet the company's clinical goals.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Define and lead overall governance system for CDMOs from strategic to daily management oversight ensuring processes and practices are compliant with global current good manufacturing practices
Partner with technical teams and program management to facilitate technical transfer of processes to new CDMOs including development and revision of batch records and procedures, management of change controls, and establishing comprehensive product specific process and equipment training programs
Review and/or author technical and project protocols and plans and reports in support of technical studies, stage gate reviews, and global regulatory filings
Acting as virtual Plant Manager and value stream team leader, partner with MSAT, QA, QC, and Supply Chain to oversee external production of clinical cell therapy products and ensure timely disposition of product
Develop and build a high performing manufacturing team to execute department responsibilities and achieve corporate and department objectives. Ensure effective engagement, integrated and collaborative execution, and robust development
Establish department, CDMO, and individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics and partner with Supply Chain and Quality to conduct periodic business reviews with each CDMO
Drive continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
Develop and manage department’s annual operating budgets; partner with Finance to analyze variances and implement adjustments
Proactively identify, assess, and mitigate operational, quality, and organizational risks escalate key risks and issues
Qualification
Required
Bachelor's degree and 15+ years of related biopharmaceutical work experience or a master's degree and 12+ years of work experience
8+ years in management / leadership positions of increasing scope and responsibility
Minimum of 5 years successfully leading late stage and/or commercial cGMP operations team in fast-paced internal and/or external manufacturing environments
Experience in cell and/or gene therapy operations (strong preference)
Strong analytical and strategic problem-solving skills; great attention to detail and the ability to drive timely and fact-based cross functional decision making in complex, high consequence scenarios
Excellent written and oral communication skills both internal and external
Proven ability to thrive as a leader in a complex and fast-paced dynamic environment, successfully building, motivating, developing, and retaining high performing teams
A leadership approach that inspires confidence, credibility, and trust internally (within and across teams) and externally
Exceptional organizational skills and record of delivering results, including robust risk management and transparent communications
Ability to grow and navigate cGMP manufacturing areas
Ability to travel domestically and internationally as needed for on-site oversight and meetings
Preferred
Preference for experience in start-up of new manufacturing capabilities / capacity
Benefits
Annual incentive bonus as a percentage of actual base salary
Long-term incentives in the form of employee stock options
Comprehensive medical, dental, and vision coverage
Company contributions to health savings and retirement accounts
Ample paid time off
Access to wellness programs
Rich career growth opportunities
Company
Obsidian Therapeutics
Obsidian Therapeutics is a developer of a next-generation cell and gene therapies created to extend adoptive immunotherapy.
51-200 employees
H1B Sponsorship
Obsidian Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$325MKey Investors
Wellington ManagementThe Column GroupGoogle Ventures
2024-04-03Series C· $160.5M
2021-09-09Series B· $115M
2017-12-06Series A· $49.5M
Leadership Team
Madan Jagasia
Chief Executive Officer
Kirsten Kester
Senior Vice President, Business Development
Recent News
2026-01-13
DelveInsight Business Research LLP
2025-10-14
Company data provided by crunchbase