Principal Scientist, Process Chemistry
Praxis
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $165,000 - $185,000 per year
Job Level
Lead
Tech Stack
SaltStack
About the role
- Leads the Process Chemistry Research and Development for one or more projects from early to late phase within Praxis.
- Designs both early phase and late-phase/commercial drug substance process and then leads their demonstration from lab to pilot plant.
- Provides chemistry and technical leadership throughout the lifecycle.
- Participates/leads activities to identify final API forms for pharmaceutical development.
- Working closely with formulations, analytical, operations, engineering and quality, expectation to be integrated into the overall CMC team responsible for delivery of clinical and commercial drug substance to Praxis programs.
- Identify, collaborate and lead external CRO, and CDMO organization(s) to achieve deliverables.
- Analyze external experimental data to drive synthetic experimental plans at CROs and CDMO.
- Authoring or co-authoring of regulatory submissions.
- Define manufacturing strategy and execution, including GMP requirements and issue resolution.
- Assessment and application of new trends and concerns in process development, quality and manufacturing to Praxis’ products.
- Manage quarterly budgeting of drug substance relevant activities.
- Contributor to inventions which add value to Praxis and its patients while strengthening our intellectual property position.
Requirements
- Advanced degree or commensurate experience equivalent in Organic Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
- Minimum of 5+ years of industry experience in CMC specifically for small molecule drug substance.
- A 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 relating to drug substances and drug products.
- Strong knowledge of CMC development across all phases of drug development from initial regulatory filings through registration, validation and launch.
- Experience in working with third-party CRO / CMO partners and associated service providers to develop and manufacturing pharmaceutical products.
- Experience with salt/crystalline form selection preferred.
- Experience with oligonucleotide chemistry is a plus.
- 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 up to 6%
- Long-term stock incentives
- Employee Stock Purchase Plan (ESPP)
- Discretionary quarterly bonus
- Flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Organic ChemistryPharmaceutical SciencesEngineeringContinuous ProcessingCatalysisBiocatalysisHigh Throughput ExperimentationcGMPCMC DevelopmentOligonucleotide Chemistry
Soft skills
Intellectual CuriosityInnovationCreative Problem SolvingInterpersonal SkillsCommunication SkillsRelationship DevelopmentOrganizational SkillsDetail-OrientedAgilityEntrepreneurial Spirit