Director, External CMC Manufacturing & Global Supply

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 210,000 - 235,000; Full time

Benefits offered by this job

401(k) matched

Stock incentives

ESPP

Discretionary quarterly bonus

Flexible wellness benefits

Generous PTO and holidays

Job summary

Praxis Precision Medicines, Inc. is seeking a Director, External Manufacturing (CMC) to lead outsourced manufacturing for clinical and future programs.

You will manage CDMOs for API and drug product, ensuring quality, regulatory compliance, and timely supply across the development lifecycle. In this hands-on, strategic role, you will build partnerships, drive technology transfer, oversee scale-up and validation, negotiate with CMOs, and implement governance and KPIs to optimize the external

Qualifications

• Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field.
• 15+ years of progressive CMC or manufacturing experience in biopharma.
• 8+ years managing external manufacturing relationships.
• 10+ years of small molecule experience.
• Experience managing global CMC supply chains in regulated environments (GMP/GDP/ICH).
• Experience overseeing drug substance and drug product manufacturing at clinical/commercial scale.
• Strong vendor management and negotiation with CMOs.

Responsibilities

• Lead strategy and management of CDMOs for drug substance and drug product.
• Interface between Praxis and external manufacturing partners.
• Oversee technology transfer, scale-up, validation, and clinical supply readiness.
• Establish and maintain Quality and Technical Agreements with partners.
• Manage end-to-end supply chain: materials, planning, logistics, inventory, distribution.
• Negotiate contracts and pricing with suppliers/CMOs to ensure cost-effective supply.

Skills

CMC leadership

external manufacturing management

vendor management

negotiation

project management

regulatory knowledge

strategic thinking

cross-functional collaboration

Education

Advanced degree in Chemistry, Chemical Engineering or Pharmaceutical Sciences

Bachelor’s degree with extensive related experience

Job description

Praxis Precision Medicines, Inc. is seeking a Director, External Manufacturing (CMC) to lead outsourced manufacturing for clinical and future programs.

You will manage CDMOs for API and drug product, ensuring quality, regulatory compliance, and timely supply across the development lifecycle. In this hands-on, strategic role, you will build partnerships, drive technology transfer, oversee scale-up and validation, negotiate with CMOs, and implement governance and KPIs to optimize the external