Senior CMC Project Leader – Remote Biotech Ops

Travere Therapeutics; San Diego (CA); On-site; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics seeks a Senior Project Manager in Technical Operations to drive CMC strategy for biologics programs, ensuring alignment with product development, clinical manufacturing, and lifecycle management. You will partner across Quality, Regulatory, Supply Chain, and Clinical Supply to reach milestones.

The role requires 7+ years in biotech/pharma, with 4+ years in PM for CMC/Manufacturing, and familiarity with GMP and process validation.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or a related discipline required.

Responsibilities

• Execute CMC strategies aligned with corporate objectives for biologics program(s).
• Develop and maintain integrated project plans, timelines, and resource forecasts.
• Ensure effective communication of project status, risks, and opportunities; improve operational efficiency.
• Facilitate team meetings, prepare agenda, publish meeting minutes, and ensure accountability for deliverables.
• Monitor project progress and proactively identify, assess, and mitigate risks.
• Coordinate CMC initiatives and activities, and partner with cross-functional teams to ensure readiness and timely delivery of technical documentation and regulatory commitments, and other CMC deliverables.

Skills

Project planning

Risk management

Stakeholder management

Communication skills

Leadership

Biologics/CMC knowledge

Education

Bachelor's in Life Sciences

Advanced degree (MS/PhD/MBA/PharmD)

Tools

Smartsheet

MS Project

PMP certification

Job description

Travere Therapeutics seeks a Senior Project Manager in Technical Operations to drive CMC strategy for biologics programs, ensuring alignment with product development, clinical manufacturing, and lifecycle management. You will partner across Quality, Regulatory, Supply Chain, and Clinical Supply to reach milestones.

The role requires 7+ years in biotech/pharma, with 4+ years in PM for CMC/Manufacturing, and familiarity with GMP and process validation.