Director, CMC & Tech Transfer

Travere Therapeutics

Manchester (NH)

On-site

USD 150,000 - 195,000

Full time

4 days ago
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Job summary

Travere Therapeutics, Inc. is seeking a Senior Director of Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in development, ensuring timely and compliant manufacturing.

You will oversee external manufacturing partners, collaborate with Quality, Regulatory, Clinical, Supply Chain, and Program Management to identify and mitigate CMC risks and achieve milestones. The role requires a Bachelor's in a relevant field and 8 years of cGMP experience, with proven

Qualifications

  • Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline.
  • 8 years of progressive cGMP related CMC drug development or manufacturing experience.
  • Leadership in CMC across multiple CMC areas and drug development with small molecules, peptides, or biologics.

Responsibilities

  • Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing activities across Phase I-III clinical development and commercial products.
  • Lead the selection, qualification, governance, and performance management of CMOs and external partners, ensuring delivery against scope, quality, timelines, and budget.
  • Oversee chemical development of new drug candidates.
  • Review regulatory filings, specifications, change controls, and Master Batch records.
  • Provide technical oversight of CMOs for developing, validating, transferring, and maintaining manufacturing and analytical methods; support regulatory inspections and audits.
  • Provide technical leadership and mentorship to colleagues and cross-functional project teams.
  • Author/edit CMC sections of regulatory submissions.
  • Additional duties as needed.

Skills

Leadership
Teamwork
Communication skills
Travel readiness

Education

Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline

Job description

Travere Therapeutics, Inc. is seeking a Senior Director of Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in development, ensuring timely and compliant manufacturing.

You will oversee external manufacturing partners, collaborate with Quality, Regulatory, Clinical, Supply Chain, and Program Management to identify and mitigate CMC risks and achieve milestones. The role requires a Bachelor's in a relevant field and 8 years of cGMP experience, with proven

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