Director, Process Chemistry

Praxis

Process chemistry director advancing small-molecule CNS medicines at Praxis Precision Medicines. Leading drug-substance development, manufacturing strategy, external partners, and regulatory submissions from early research through commercial supply.

Posted 8/4/2026full-timeRemote • 🇺🇸 United StatesLead💰 $210,000 - $230,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading drug substance activities and process chemistry research for small-molecule programs, with a strong focus on CMC development, regulatory submissions, and compliance with cGMP requirements. Proven ability to collaborate across teams and manage external partnerships to drive successful pharmaceutical product development.

Highest-signal resume keywords

Drug Substance DevelopmentProcess Chemistry ResearchCMC DevelopmentRegulatory SubmissionsCGMP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ChemistryPharmaceutical SciencesEngineeringContinuous ProcessingBiocatalysisCatalysisHigh-Throughput ExperimentationSalt/Crystalline Form SelectionOligonucleotide ChemistryManufacturing Strategy

Soft Skills

Interpersonal SkillsCommunication SkillsOrganizational SkillsDetail-OrientedCreative Problem Solving

Tools & Technologies

CROCDMOGMP Requirements

Industry Keywords

Small-Molecule ProgramsPharmaceutical DevelopmentRegulatory FilingsValidationLaunch

Tech Stack

Tools & technologies

SaltStack

About the role

Key responsibilities & impact

Lead drug substance activities for one or more small-molecule programs from clinical development through commercial readiness
Lead process chemistry research and development for projects from early to late phase
Design early-phase and late-phase/commercial drug substance processes and lead demonstration from laboratory to pilot plant
Provide chemistry and technical leadership throughout the product lifecycle
Lead or participate in identifying final API forms for pharmaceutical development
Collaborate with formulation, analytical, operations, engineering, and quality teams within the CMC organization
Identify, collaborate with, and lead external CRO and CDMO organizations to achieve deliverables
Analyze external experimental data to drive synthetic experimental plans at CROs and CDMOs
Author or co-author regulatory submissions
Define manufacturing strategy and execution, including GMP requirements and issue resolution
Assess and apply new trends and concerns in process development, quality, and manufacturing
Manage quarterly budgeting for drug-substance-related activities
Contribute to inventions that strengthen Praxis’ intellectual property position and add value for patients

Requirements

What you’ll need

Advanced degree or commensurate equivalent experience in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline
Minimum 12 years of industry experience in CMC specifically for small-molecule drug substance
Strong knowledge of US and EU cGMP requirements and best practices for drug substances and drug products
Strong knowledge of CMC development across all phases, from initial regulatory filings through registration, validation, and launch
Experience working with third-party CRO/CMO partners and service providers to develop and manufacture pharmaceutical products
Scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high-throughput experimentation is desirable
Experience with salt/crystalline form selection is preferred
Experience with oligonucleotide chemistry is a plus
High intellectual curiosity, innovation, creative problem solving, entrepreneurial spirit, and ability to thrive in an agile environment
Excellent interpersonal and communication skills, with ability to develop trusted relationships and encourage diversity
Highly organized and detail-oriented, with passion for delivering quality results
Flexibility and willingness to travel as needed

Benefits

Comp & perks

99% of medical, dental and vision plan premiums paid
Company-paid life insurance
AD&D benefits
Disability benefits
Voluntary plans to personalize coverage
Dollar-for-dollar 401(k) matching up to 6% on eligible contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns