SIGN IN
Principal Scientist, Analytical Development, Oligo and Small Molecule jobs in United States
info-icon
This job has closed.
company-logo

Praxis Precision Medicines, Inc. · 1 month ago

Principal Scientist, Analytical Development, Oligo and Small Molecule

Praxis Precision Medicines, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Principal Scientist in Analytical Development will be responsible for advancing oligonucleotide-based therapeutics and supporting small molecule programs, ensuring robust analytical strategies across various teams and external partners.
WellnessBiotechnologyHealthcareMedical DeviceAlternative MedicineHealth CareMedicalPrecision Medicine
check
Comp. & Benefits
check
H1B Sponsor Likelynote

Responsibilities

Serve as Analytical Lead across CMC programs, with primary responsibility for oligonucleotide analytical development activities and support for small molecule programs
Lead analytical method development, qualification, validation, transfer, and GMP testing activities across internal teams and external partners
Drive technical troubleshooting, data interpretation, method lifecycle management, and review of analytical documentation including validation reports, stability reports, specifications, and CoAs
Design and implement phase-appropriate analytical control strategies, specifications, and stability programs for oligonucleotide and small molecule drug substances and drug products
Direct and manage CRO/CMO analytical partners to ensure high-quality execution, strong communication, and continuous operational improvement
Collaborate cross-functionally to strengthen CMC operations, improve processes, and establish scalable technical and business practices across the analytical function
Contribute strategic and technical expertise to support regulatory filings, commercialization readiness, and ongoing product lifecycle management

Qualification

Analytical method developmentAnalytical method qualificationAnalytical method validationGMP testingOligonucleotide drug substancesOligonucleotide drug productsSmall molecule drug substancesImpurity characterizationStability assessmentCGMP requirementsCMC developmentRegulatory submissionsQuality systemsReference standardsCompendial testingCRO/CMO managementScientific judgment

Required

Advanced degree (PhD preferred; Master's with significant industry experience considered) in Analytical Chemistry or related discipline with 5–7+ years of industry experience
Strong industry experience in analytical development for oligonucleotide drug substances and/or drug products required
Deep knowledge of analytical techniques relevant to oligonucleotides, including impurity characterization, stability assessment, and GMP control strategies
Strong understanding of US and EU cGMP requirements and analytical best practices for drug substance and drug product development
Experience supporting CMC development across multiple stages of development, including regulatory submissions, validation, and commercialization activities
Experience managing external CRO/CMO analytical networks and building productive technical partnerships
Strong working knowledge of quality systems, reference standards, stability programs, and compendial testing requirements

Preferred

Experience supporting small molecule drug substances and solid oral dosage forms strongly preferred

Benefits

99% of the premium paid for medical, dental and vision plans
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
Long-term stock incentives and ESPP
Discretionary quarterly bonus
An extremely flexible wellness benefit
Generous PTO
Paid holidays and company-wide shutdowns

Company

Praxis Precision Medicines, Inc.

twitterlinkedincrunchbase
company-logo
Praxis Precision Medicines is a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance.

H1B Sponsorship

Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
100%
Represents job field similar to this job
Engineering and Development
Trends of Total Sponsorships
*2024 (1)

Funding

Current Stage
Public Company
Total Funding
$1.67B
Key Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M

Leadership Team

leader-logo
Marcio Souza
President and CEO
linkedin
leader-logo
Tim Kelly
Chief Financial Officer
linkedin
Company data provided by crunchbase