Director of Technical Operations — External Manufacturing Lead

ARS Pharmaceuticals Inc.

San Diego (CA)

On-site

USD 225,000 - 275,000

Full time

2 days ago
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Benefits offered by this job

Equity
401k matching
Medical, dental & vision for employees

Job summary

ARS Pharmaceuticals is seeking a Director/Senior Director, Technical Operations to lead external manufacturing and the outsourced network for neffy. You will shape strategy, govern CMOs, and drive technology transfer, process validation, and lifecycle management to ensure reliable supply.

Based in San Diego, this full-time role partners with Regulatory, Quality, and Commercial teams to align manufacturing plans with regulatory commitments and business needs.

Qualifications

  • Bachelor’s degree in pharmaceutical sciences or related field; 10+ years in Technical Operations.
  • Experience managing external CMOs/CDMOs in outsourced models.
  • Strong leadership, governance, budgeting, and risk management skills.
  • Experience with regulatory CMC strategy is preferred.

Responsibilities

  • Provide leadership for Technical Operations programs and external manufacturing strategies.
  • Own senior-level Technical Operations relationships with CMOs/CDMOs; governance and performance review.
  • Lead formulation, scale-up, technology transfer, process validation, and lifecycle management.
  • Coordinate manufacturing campaigns, product launches, and supply requirements.
  • Oversee documentation, investigations, CAPAs, and change controls with QA.
  • Establish KPIs and drive continuous improvement across the external network.
  • Represent Operations on cross-functional leadership teams and align with regulatory commitments.
  • Travel up to 25% domestically and internationally.

Skills

cGMP knowledge
External manufacturing leadership
Strategic operations planning
Regulatory affairs collaboration

Education

Bachelor’s degree in pharmaceutical sciences
MS/PhD or MBA preferred

Tools

MS Office

Job description

ARS Pharmaceuticals is seeking a Director/Senior Director, Technical Operations to lead external manufacturing and the outsourced network for neffy. You will shape strategy, govern CMOs, and drive technology transfer, process validation, and lifecycle management to ensure reliable supply.

Based in San Diego, this full-time role partners with Regulatory, Quality, and Commercial teams to align manufacturing plans with regulatory commitments and business needs.

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