Cell Therapy Manufacturing & CDMO Lead

Obsidian Therapeutics

Bedford (MA)

Hybrid

GBP 85,000 - 124,000

Full time

7 days ago
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Benefits offered by this job

Stock options
Competitive salary & benefits
Annual incentive bonus
Health, dental, vision insurance

Job summary

Obsidian Therapeutics is seeking a Senior Manager/Associate Director External Manufacturing to lead front-line oversight of viral vector and ancillary material production. You’ll manage CDMO partnerships, drive deviation management, change control, and continuous improvement across the network in support of our autologous cell therapy programs.

You will partner with QA, MS&T, QC, CMC PM and Supply Chain to ensure manufacturing readiness, schedule adherence, and cost optimization, while

Qualifications

  • Senior Manager 8+ (MS 6+) years of experience in manufacturing or MS&T roles in biotech/pharma.
  • Experience leading outsourced manufacturing operations across CDMOs with tech transfer and late-stage production.
  • GMP quality system knowledge and strong project management skills.

Responsibilities

  • Oversee viral vector and ancillary material manufacturing across a CDMO network to ensure supply to the clinic.
  • Manage deviation management, change control, and continuous improvement initiatives across manufacturing networks.
  • Coordinate with QA, MS&T, QC, CMC PM, and Supply Chain to ensure systems are fit for purpose and manufacturing readiness.
  • Coach CDMOs on phase-appropriate standards and ensure budget reporting and cost control.

Skills

CDMO management
Viral vector manufacturing
Change control
Lean manufacturing
Cross-functional leadership

Education

Bachelor's Degree in Life Sciences, Engineering, or related discipline

Tools

MES integrated systems

Job description

Obsidian Therapeutics is seeking a Senior Manager/Associate Director External Manufacturing to lead front-line oversight of viral vector and ancillary material production. You’ll manage CDMO partnerships, drive deviation management, change control, and continuous improvement across the network in support of our autologous cell therapy programs.

You will partner with QA, MS&T, QC, CMC PM and Supply Chain to ensure manufacturing readiness, schedule adherence, and cost optimization, while

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