Senior Manager, External Manufacturing

Obsidian Therapeutics

Senior Manager leading CDMO management in External Manufacturing for cell therapy at Obsidian Therapeutics. Collaborating with teams to ensure supply chain continuity and high-quality clinical product.

Posted 6/23/2026full-timeBedford • Massachusetts • 🇺🇸 United StatesSenior💰 $153,000 - $187,000 per yearWebsite

About the role

Key responsibilities & impact

Develop proficiency in Obsidian’s drug product and drug substance manufacturing processes.
Oversee execution of drug product and ancillary drug substance manufacturing across a network of global CDMO partners to ensure supply chain continuity and high-quality supply to the clinic.
Manage or collaborate on CDMO investigations, MBR revisions, and change controls as needed to enable on time production and lot disposition.
Oversee CDMO performance metrics for manufacturing and internal stakeholders demonstrating strategic areas of focus and continuous improvement opportunities.
Contribute to cost-of-goods (COGS) optimization and value creation by leading continuous improvement initiatives with CDMO partners.
Participate in strategic sourcing, vendor selection, capacity planning, SOW/ forecast review, and ongoing supplier relationship management for key services.
Partner closely with Quality, MS&T, QC, CMC and Supply Chain to ensure systems are fit for purpose for program phase.
Coach CDMOs on phase appropriate standards for operations, including scheduling, operational performance metrics, batch release, equipment maintenance, and financial reporting.
Foster a high-performance culture with CDMO partners and internally.
Enable team success and individual growth through clear expectations, high standards/support, stretch assignments, and coaching.

Requirements

What you’ll need

Bachelor's Degree in Life Sciences, Engineering, or related discipline with 8+ years of experience in manufacturing or MS&T roles in the biotech/pharma industry.
Deep experience managing contract manufacturing and external supply networks, ideally in cell and gene therapy or other complex modalities.
Deep experience with batch record design, implementation of EBRs and MES integrated systems
Proficiency with Lean tools and techniques
Strong understanding of GMP compliance, quality systems, and regulatory expectations for advanced therapies
Proficiency with SOW/ Change order creation, CDMO financial reporting and budget management
Demonstrated ability to lead cross-functional teams to achieve ambitious goals, manage complex projects, and influence at all levels of the organization
Ability to travel 20-40% of time
Excellent planning, coordination, and time management skills
Excellent oral, written, and visual communication skills.
A desire and ability to work in a dynamic, collaborative environment; building productive and healthy relationships within and across functions
Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and constructively challenge and accept challenges to generate the best ideas to advance project and company goals.
Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.
Flexible – able to operate and adapt 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, operates with urgency.

Benefits

Comp & perks

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
annual incentive bonus as a percentage of actual base salary
long-term incentives in the form of employee stock options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

drug product manufacturingdrug substance manufacturingCDMO managementbatch record designEBR implementationMES integrated systemsLean toolsGMP complianceSOW creationbudget management

Soft Skills

leadershipplanningcoordinationtime managementcommunicationcollaborationaccountabilityself-motivationflexibilityresilience

Certifications

Bachelor's Degree in Life SciencesBachelor's Degree in Engineering