Director, CMC External Manufacturing

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

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

The Director, External Manufacturing (CMC) will lead and manage outsourced manufacturing operations supporting Praxis’s clinical and future commercial programs. This role will oversee Contract Development and Manufacturing Organizations (CDMOs) responsible for drug substance (API) and drug product manufacturing, ensuring high-quality, compliant, and timely supply of clinical materials. The ideal candidate is a strategic, hands‑on CMC leader experienced in managing external partnerships and driving operational excellence in a dynamic biotech environment.

Primary Responsibilities

• Lead the strategy, selection, and management of CDMOs for both 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 robust Quality and Technical Agreements with manufacturing partners.
• Manage and optimize the end‑to‑end supply chain process, including raw materials procurement, production planning, logistics, inventory management, and distribution.
• Lead supplier qualification, monitoring, and performance evaluations, addressing risks and identifying opportunities for improvement.
• Negotiate contracts and pricing agreements with suppliers and CMOs to achieve cost‑effective outcomes while maintaining supply security.

CMC Operations and Program Support

• Collaborate closely with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams to ensure seamless execution of CMC deliverables.
• Support CMC development strategies aligned with clinical timelines, regulatory expectations, and company objectives.
• Manage manufacturing planning, scheduling, and inventory to ensure uninterrupted clinical supply.

Governance, Compliance, and Continuous Improvement

• Ensure all outsourced manufacturing is performed under appropriate GMP and regulatory standards.
• Implement key performance indicators (KPIs) and governance mechanisms to monitor and improve CDMO performance.
• Proactively identify and mitigate technical and operational risks across the external supply network.
• Drive operational excellence and process improvements to enhance efficiency and compliance.

Qualifications And Key Success Factors

• Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor’s degree with extensive relevant experience considered.
• 15+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry, including ≥8 years managing external manufacturing relationships.
• 10+ years of small molecule experience.
• Proven experience in managing global CMC supply chains for commercial products in a regulated environment. Includes 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 and/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.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You’ll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

• At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.
• This includes 99% of the premium paid for medical, dental and vision plans.
• We also provide company‑paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• We match dollar‑for‑dollar up to 6% on eligible 401(k) contributions.
• We sweeten the deal with long‑term stock incentives and ESPP.
• We provide a discretionary quarterly bonus.
• We offer an extremely flexible wellness benefit.
• We provide generous PTO, paid holidays and company‑wide shutdowns.

To round out our world‑class total rewards package, we provide annualized base salary in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job‑related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Annualized Base Salary: $210,000 USD - $235,000 USD

Company Overview

Praxis Precision Medicines is a clinical‑stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.