Senior External Manufacturing Lead, Viral Vectors

Socket.dev; Bedford (MA); Hybrid; USD 116,000 - 168,000; Full time

Benefits offered by this job

Stock options

Competitive benefits

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 establish a new manufacturing specialist function for deviation management, change control, and continuous improvement across the network of CDMOs.

You will collaborate with QA, MS&T, QC, and Supply Chain to ensure systems are fit for purpose, drive cost reductions, and enable on-time manufacturing for our autologous cell

Qualifications

• Bachelor's degree in life sciences, engineering, or related discipline.
• Senior Manager 8+ years or Associate Director 10+ years in manufacturing/ MS&T in biotech/pharma.
• Experience leading outsourced manufacturing with CDMOs, including tech transfers and late-stage production.
• Experience designing batch records, EBRs, and MES integrated systems.
• Deep GMP quality systems, deviation management, change control, risk management.

Responsibilities

• Oversee viral vector and ancillary material manufacturing across CDMOs to ensure supply and quality.
• Lead deviation management, change control, MBR/EBR revisions, and continuous improvement initiatives.
• Coach CDMOs on phase-appropriate standards for operations and validation.
• Collaborate with QA, MS&T, QC, and Supply Chain to ensure systems are fit for program needs.
• Drive cost-of-goods optimization and strategic sourcing with vendors.

Skills

CDMO management

Viral vector manufacturing

Quality systems

Lean manufacturing

Regulatory understanding

Cross-functional leadership

Project planning

Vendor partnerships

Education

Bachelor's Degree in Life Sciences or Engineering

Tools

MES

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 establish a new manufacturing specialist function for deviation management, change control, and continuous improvement across the network of CDMOs.

You will collaborate with QA, MS&T, QC, and Supply Chain to ensure systems are fit for purpose, drive cost reductions, and enable on-time manufacturing for our autologous cell