Senior Manager, External Manufacturing — Viral Vectors

Socket.dev

Bedford (MA)

Hybrid

USD 153,000 - 220,000

Full time

14 days+
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Benefits offered by this job

Medical, dental, and vision coverage
401(k) retirement contributions
Generous PTO
Wellness programs
Career growth opportunities

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 across CDMOs for the company’s autologous cell therapy programs.

You will manage manufacturing value streams, ensure scheduling, training, investigations, and continuous improvement across the manufacturing network, partnering with QA, MS&T, QC, CMC PM, and Supply Chain.

Qualifications

  • Bachelors degree in Life Sciences, Engineering, or related discipline.
  • Senior Manager 8+ (MS 6+), Associate Director 10+ (MS 8+) years in manufacturing or MS&T in biotech/pharma.
  • Experience leading outsourced manufacturing across CDMOs and tech transfers.
  • Lean manufacturing, quality systems and GMP knowledge.

Responsibilities

  • Oversee viral vector and ancillary material manufacturing across a network of CDMOs.
  • Ensure adherence to production scheduling and site PIP management.
  • Lead investigations, batch record revisions, and change controls.
  • Drive continuous improvement and CDMO operational readiness.
  • Collaborate with QA, MS&T, QC, CMC PM and Supply Chain to ensure fit-for-purpose systems.

Skills

CDMO management
Viral vector manufacturing
Operations leadership
GMP compliance
Cross-functional collaboration
Project management
Lean manufacturing
Budget planning
Vendor management

Education

Bachelor's degree in Life Sciences/Engineering

Tools

MES (Manufacturing Execution System)
GMP documentation tools

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 across CDMOs for the company’s autologous cell therapy programs.

You will manage manufacturing value streams, ensure scheduling, training, investigations, and continuous improvement across the manufacturing network, partnering with QA, MS&T, QC, CMC PM, and Supply Chain.

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