Senior Manager, External Manufacturing — Biotech (Hybrid + Stock Options)

Obsidian Therapeutics; Bedford (MA); Hybrid; USD 153,000 - 220,000; Full time

Job summary

Obsidian Therapeutics seeks a Senior Manager/Associate Director External Manufacturing to lead front-line oversight of viral vector and ancillary material production. You will drive manufacturing across CDMOs, manage deviations and change controls, and support a first autologous cell therapy program.

Based in our Bedford, MA facility with a hybrid work model, you will optimize COGS, lead SOW discussions, and mentor a high-performing team while collaborating with QA, MS&T, QC, and Supply Chain.

Qualifications

• Bachelor's degree and 8+ years (Senior Manager) or 10+ (Assoc Director) in manufacturing or MS&T in biotech/pharma.
• Demonstrated success leading outsourced manufacturing operations across a network of CDMOs.
• Extensive experience designing and implementing batch records, EBRs, and MES integrated systems.
• Deep experience in quality systems, deviation management, root cause analysis, change control, and risk management in GMP.
• Proficiency in developing and managing SOWs, change orders, contract negotiations, CDMO budget planning, financial reporting.
• 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 25-30% of time.
• Excellent planning, coordination, and time management skills.
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
• A desire and ability to work in a dynamic, collaborative environment; building productive and healthy relationships within and across functions.
• 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.
• Excellent organizational skills;able to managemultiple tasks of varying degrees of complexityin parallel.
• Remains calm under pressure andleadsothers through complex situations.
• Seeksthedata,information,and supportneeded(internally and externally)tomakeefficient andinformed decisionsandmeetobjectives.
• 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 examplewith a growth mindset.

Responsibilities

• Oversee viral vector and ancillary drug substance manufacturing across a network of CDMO partners to ensure supply continuity and quality.
• Coordinate production scheduling, CDMO training, site PIP management, and batch release readiness.
• Triage investigations, review batch records/MBRs/EBRs, and drive continuous improvement projects.
• Monitor CDMO performance metrics and translate into actionable improvements for internal stakeholders.
• Collaborate with QA, MS&T, QC, CMC PM and Supply Chain to ensure processes are fit for program needs.

Skills

CDMO management

Viral vector production

Manufacturing operations

Quality systems

GMP regulations

Cross-functional leadership

Budget management

Training/mentoring

Project management

Lean manufacturing

Education

Bachelor's Degree in Life Sciences or related

Tools

MES systems

SOW management tools

Job description

Obsidian Therapeutics seeks a Senior Manager/Associate Director External Manufacturing to lead front-line oversight of viral vector and ancillary material production. You will drive manufacturing across CDMOs, manage deviations and change controls, and support a first autologous cell therapy program.

Based in our Bedford, MA facility with a hybrid work model, you will optimize COGS, lead SOW discussions, and mentor a high-performing team while collaborating with QA, MS&T, QC, and Supply Chain.