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Senior Director, Process Chemistry CMC

United States - Remote

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

The Opportunity

As Senior Director of Process Chemistry, you’ll serve as a strategic and technical leader across Praxis’ portfolio of small molecule and ASO programs. You’ll be responsible for the design, development, and execution of drug substance strategies—from early clinical to commercial launch—with an eye toward innovation, scalability, and speed. You’ll shape long-term CMC strategies, guide external partnerships, and ensure that process development decisions align with regulatory, operational, and business goals.  You’ll operate as a key voice in project and functional leadership, integrating scientific insight, business acumen, and mission-driven urgency to unlock transformative treatments for CNS disorders.

This role is ideal for someone who thrives in a fast-moving, collaborative environment, where science meets ownership. You’ll help define product requirements, anticipate challenges, and co-create practical, creative solutions that accelerate progress for patients in urgent need.

Primary Responsibilities

  • Serve as the strategic lead for Process Chemistry across multiple programs and phases, ensuring coherent and forward-looking plans for API development, manufacturing, and regulatory success.
  • Lead design, development, scale-up, and technology transfer of drug substance processes, including evaluation and implementation of enabling technologies (e.g., continuous manufacturing, biocatalysis).
  • Drive API form selection, CMC strategy, and regulatory documentation from IND through commercial filings.
  • Partner with Formulations, Analytical, Quality, Regulatory, and Clinical Supply to deliver on end-to-end CMC execution and risk mitigation.
  • Build, manage, and mentor a high-performing internal and external technical team (CRO/CDMO partners), ensuring performance and accountability.
  • Shape Praxis’ approach to external manufacturing, including vendor selection, contract negotiation, and governance.
  • Translate business and regulatory requirements into technical strategy—ensuring speed, scalability, and compliance.
  • Provide thought leadership in process chemistry innovation and represent Praxis at scientific and regulatory forums as needed.

Qualifications and Key Success Factors

  • Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline; 15+ years of industry experience with increasing responsibility in process development and CMC leadership.
  • Demonstrated success leading API strategy from development through commercialization, including experience with regulatory filings (IND, IMPD, NDA/MAA).
  • Deep knowledge of US and EU cGMP requirements and emerging trends in process chemistry and manufacturing technologies.
  • Strong record of vendor management, tech transfer, and external partnership leadership across global networks.
  • Experience working with oligonucleotides and small molecules preferred.
  • Proven ability to influence across functions and levels, integrating technical, regulatory, and business perspectives.
  • High ownership, scientific rigor, and strategic agility—able to thrive in a dynamic, mission-driven environment.
  • 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. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Annualized Base Salary

$250,000 - $270,000 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.

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