Director, CMC External Manufacturing

The role

The Director, External Manufacturing (CMC) will lead and manage outsourced manufacturing operations for clinical and future commercial programs. This role oversees CDMOs for drug substance and drug product manufacturing to ensure supply of clinical materials.

What you will do

• Lead the strategy, selection, and management of CDMOs for drug substance and drug product manufacturing.
• 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 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 with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams.
• Manage manufacturing planning, scheduling, and inventory.
• Ensure outsourced manufacturing is performed under appropriate GMP and regulatory standards.

Required qualifications

• 15+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry.
• 8+ years managing external manufacturing relationships.
• 10+ years of small molecule experience.
• Experience managing global CMC supply chains for commercial products in a regulated environment.
• Understanding of GMP, GDP, and ICH guidelines.
• Experience overseeing both drug substance and drug product manufacturing at clinical and/or commercial scale.
• Negotiation and vendor management abilities including experience working with CMOs.
• Ability to manage complex projects and external relationships.
• Ability to navigate complex regulatory and compliance requirements.
• Regular use of a computer, devices or other office equipment.
• Clear communication.
• Occasional movement, screen work, basic hand coordination, and focus.

Nice to have

• Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance, AD&D, and disability benefits
• Voluntary plans to personalize coverage
• 401(k) match dollar-for-dollar up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays
• Company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.