Remote Associate Director, Technical Operations & CMC

Ladders

United States

Remote

USD 150,000 - 195,000

Full time

5 days ago
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Benefits offered by this job

Premium health insurance
Wellness programs
Life insurance
Retirement plans with employer match
Generous paid time off

Job summary

Ladders is seeking an Associate Director, Technical Operations for a client in Pharmaceuticals & Biotech. This remote-US role guides technical operations across clinical and commercial programs with emphasis on technology transfer, scale-up, validation, and external manufacturing support.

You will leverage deep CMC and cGMP expertise to ensure high-quality execution, regulatory readiness, and timely delivery while partnering with internal cross-functional teams and external CMOs.

Qualifications

  • Bachelor's degree in Process or Chemical Engineering, Life Sciences, or a related discipline required
  • 8 years of progressive cGMP-related CMC drug development or manufacturing experience required
  • Demonstrated leadership experience in multiple CMC areas, particularly with small molecules, peptides, and biologics
  • Manufacturing experience with oral solid dosage forms preferred
  • Ability to adapt and implement new strategies in response to project changes

Responsibilities

  • Lead technology transfer, scale-up, validation, and manufacturing for clinical and commercial products
  • Manage the performance of external manufacturing partners to ensure they meet quality and timeline requirements
  • Oversee chemical development of new drug candidates
  • Review key regulatory documents and maintain compliance with cGMP requirements
  • Provide technical oversight for contract manufacturing organizations on manufacturing processes and methods
  • Mentor colleagues and cross-functional teams in CMC processes
  • Author and edit CMC sections of regulatory submissions

Skills

CMC leadership
Regulatory compliance
Cross-functional collaboration
Process development

Education

Bachelors in engineering or life sciences

Job description

Ladders is seeking an Associate Director, Technical Operations for a client in Pharmaceuticals & Biotech. This remote-US role guides technical operations across clinical and commercial programs with emphasis on technology transfer, scale-up, validation, and external manufacturing support.

You will leverage deep CMC and cGMP expertise to ensure high-quality execution, regulatory readiness, and timely delivery while partnering with internal cross-functional teams and external CMOs.

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