Principal Scientist, Process Chemistry

Praxis

Principal Scientist leading small-molecule drug substance process development for Praxis, a CNS biopharmaceutical company translating genetic insights into therapies. Driving CMC strategy, manufacturing scale-up, CRO/CDMO execution and regulatory submissions from clinical development through commercial supply.

Posted 8/4/2026full-timeRemote • 🇺🇸 United StatesLead💰 $165,000 - $185,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Process Chemistry Research and Development, with a strong focus on CMC for small-molecule drug substances, regulatory submissions, and GMP compliance. Proven ability to lead cross-functional teams and manage external partnerships to deliver high-quality pharmaceutical products.

Highest-signal resume keywords

Process Chemistry Research And DevelopmentCMC Development For Small-Molecule Drug SubstanceRegulatory SubmissionsUS And EU cGMP RequirementsCollaboration With CRO And CDMO

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Organic ChemistryPharmaceutical SciencesContinuous ProcessingCatalysisBiocatalysisHigh-Throughput ExperimentationSalt/Crystalline Form SelectionOligonucleotide ChemistryManufacturing StrategyBudget Management

Soft Skills

Interpersonal SkillsCommunication SkillsCreative Problem-SolvingOrganizational SkillsDetail-Oriented

Industry Keywords

Drug Development PhasesRegulatory FilingsValidationLaunchIntellectual Property

Tech Stack

Tools & technologies

SaltStack

About the role

Key responsibilities & impact

Lead Process Chemistry Research and Development for one or more projects from early to late phase
Design early-phase and late-phase/commercial drug substance processes and lead their demonstration from laboratory to pilot plant
Provide chemistry and technical leadership throughout the product lifecycle
Participate in or lead activities identifying final API forms for pharmaceutical development
Work with formulations, analytical, operations, engineering and quality teams within the CMC team to deliver clinical and commercial drug substance
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 of drug-substance-relevant activities
Contribute to inventions that add value to Praxis and patients while strengthening intellectual property

Requirements

What you’ll need

Advanced degree or commensurate experience equivalent in Organic Chemistry, Pharmaceutical Sciences, Engineering or a related discipline
Minimum 5+ years of industry experience in CMC specifically for small-molecule drug substance
Scientific track record or working knowledge in continuous processing, catalysis, biocatalysis and/or high-throughput experimentation desirable
Strong knowledge of US and EU cGMP requirements and best practices for drug substances and drug products
Strong knowledge of CMC development across all drug-development phases, from initial regulatory filings through registration, validation and launch
Experience working with third-party CRO/CMO partners and associated service providers to develop and manufacture pharmaceutical products
Experience with salt/crystalline form selection preferred
Experience with oligonucleotide chemistry is a plus
Intellectual curiosity, innovation, creative problem-solving ability and an entrepreneurial spirit
Ability to thrive in an agile environment
Excellent interpersonal and communication skills
Ability to develop trusted relationships and encourage diversity
Highly organized and detail-oriented, with a passion for delivering quality results

Benefits

Comp & perks

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