Associate Director, External Manufacturing – CMC
Praxis
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $170,000 - $190,000 per year
Job Level
Senior
About the role
- Support outsourced manufacturing operations supporting Praxis’s clinical and future commercial programs
- Oversee Contract Development and Manufacturing Organizations (CDMOs) responsible for drug substance (API) and drug product manufacturing
- Ensure high-quality, compliant, and timely supply of clinical materials
- Serve as the primary operational interface between Praxis and external manufacturing partners
- Oversee technology transfer, process scale-up, validation, and clinical supply readiness
- Establish and maintain robust Quality and Technical Agreements with manufacturing partners
- Manage and optimize the end-to-end supply chain process
- Lead supplier qualification, monitoring, and performance evaluations
- Negotiate contracts and pricing agreements with suppliers and CMOs
- Collaborate closely with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams
- Manage manufacturing planning, scheduling, and inventory to ensure uninterrupted clinical supply
- Ensure all outsourced manufacturing is performed under appropriate GMP and regulatory standards
- Implement key performance indicators (KPIs) and governance mechanisms
- Proactively identify and mitigate technical and operational risks across the external supply network
- Drive operational excellence and process improvements
Requirements
- Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor’s degree with extensive relevant experience considered
- 10+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry, including ≥8 years managing external manufacturing relationships
- Proven experience in managing global CMC supply chains for commercial products in a regulated environment
- Strong understanding of GMP, GDP, and ICH guidelines and their application in a commercial setting
- Demonstrated experience overseeing both drug substance and drug product manufacturing at clinical or commercial scale
- Excellent negotiation and vendor management abilities including experience working with CMOs and managing third-party relationships
- Proven ability to manage complex projects and external relationships with technical and business acumen
- Ability to navigate complex regulatory and compliance requirements
Benefits
- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
- 401(k) matching up to 6% on eligible contributions
- Long-term stock incentives and ESPP
- Discretionary quarterly bonus
- Flexible wellness benefit
- Generous PTO
- Paid holidays and company-wide shutdowns
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
drug substance manufacturingdrug product manufacturingtechnology transferprocess scale-upvalidationsupply chain managementcontract negotiationperformance evaluationGMP complianceKPI implementation
Soft skills
negotiationvendor managementproject managementrelationship managementoperational excellencerisk mitigationcollaborationcommunicationleadershipproblem-solving