Principal Scientist, Analytical Development
Praxis
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $162,000 - $182,000 per year
Job Level
About the role
- Responsible for translating the processes and products for Praxis’ clinical and commercial pipeline from the laboratory to the manufacturing environment.
- Use knowledge of analytical method development, qualification, validation, and troubleshooting to deliver to Analytical Team.
- Strong collaboration with Drug Substance/Drug Product scientists, engineers, Quality and manufacturing to ensure efficiency and control.
- Lead contributing to ensuring the analytical function is agile and at the forefront in the industry.
- Deliver to product teams within CMC to realize Praxis’ pipeline of innovative medicines for neurological disease.
- Involved in all analytical deliverables with CMC program while acting as Analytical lead, including management and execution of analytical testing.
Requirements
- Advanced degree (PhD or Masters degree with related experience) in Analytical Chemistry or related discipline with 5-7 years of industry experience.
- Industry experience in Analytical Development specifically for small molecule drug substance and solid oral drug products is required.
- Experience with oligonucleotide drug substance and/or drug products desirable.
- Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.
- Ability to interpret and implement, as appropriate, compendia-based testing requirements for drug substances and drug products.
- Involvement in reference standard management and stability oversight.
- Experience with CMC development and support across all phases of drug development from initial regulatory filings through registration, validation, and launch preferred.
- Experience in support of late-stage/commercial products including product monitoring, improvement and issue resolution preferred.
- Demonstrated success in building and maintaining productive partnerships with third-party CRO/CMO partners and associated service providers to develop and manufacturing pharmaceutical products.
- Fluid and conversant with GMP and quality control.
- Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
- Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.
- Highly organized and detail-oriented with a passion to deliver quality results.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits.
- Voluntary plans to personalize your coverage.
- 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO, paid holidays and company-wide shutdowns.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical method developmentqualificationvalidationtroubleshootingCMC developmentreference standard managementstability oversightdrug substancedrug productsoligonucleotide
Soft Skills
collaborationcommunicationorganizationalproblem solvingintellectual curiosityinnovationagilityrelationship buildingtrustdetail-oriented
Certifications
PhDMasters degree