Director, External CMC Manufacturing & Partnerships

Praxis Precision Medicines; United States; Remote; USD 210,000 - 235,000; Full time

Benefits offered by this job

Medical, dental & vision plans (world‑

Company-paid life insurance

AD&D

Disability benefits

401(k) match up to 6%

Stock incentives and ESPP

Discretionary quarterly bonus

Flexible wellness benefit

PTO & paid holidays

Job summary

Praxis Precision Medicines is seeking a Director, External Manufacturing (CMC) to lead outsourced drug substance and drug product manufacturing. You will partner with CDMOs, drive tech transfer, and ensure regulatory compliance while maintaining supply for clinical programs.

The role demands 15+ years in CMC/manufacturing and deep experience with external partnerships, scale-up, and risk management in a biotech setting.

Qualifications

• 15+ years of progressive CMC or manufacturing experience in biopharma
• ≥8 years managing external manufacturing relationships
• 10+ years of small molecule experience
• Strong GMP, GDP, and ICH knowledge for commercial settings

Responsibilities

• Lead strategy, selection, and management of CDMOs for drug substance and drug product
• Interface with Praxis and external manufacturing partners
• Oversee tech transfer, scale-up, validation, and clinical supply readiness
• Establish and maintain Quality and Technical Agreements with partners
• Manage end-to-end supply chain: procurement, planning, logistics, inventory and distribution
• Lead supplier qualification, monitoring, and performance evaluations
• Negotiate contracts and pricing with CMOs to balance cost and supply security
• Collaborate with Process Chemistry, Formulation, Analytical, Quality, Regulatory teams
• Support development strategies aligned with timelines and regulatory expectations
• Manage manufacturing planning, scheduling, and inventory for clinical supply
• Ensure outsourced manufacturing meets GMP and regulatory standards
• Implement KPIs and governance for CDMO performance
• Mitigate risks across the supply network
• Drive continuous improvement in efficiency and compliance

Skills

CDMO management

External manufacturing

GMP compliance

Vendor management

Regulatory knowledge

Education

Advanced degree in Chemistry/Engineering/Pharma

Job description

Praxis Precision Medicines is seeking a Director, External Manufacturing (CMC) to lead outsourced drug substance and drug product manufacturing. You will partner with CDMOs, drive tech transfer, and ensure regulatory compliance while maintaining supply for clinical programs.

The role demands 15+ years in CMC/manufacturing and deep experience with external partnerships, scale-up, and risk management in a biotech setting.