Principal Scientist, Process Chemistry
About The Position
We’re seeking a Principal Scientist in Process Chemistry to lead drug substance activities for one or more projects within Praxis’ portfolio to support clinical and commercial supply. Apply your knowledge to design products & processes to support clinical phase testing and then mature them through development to commercial supply. You are a key leader in the development of drug substance processes for our small molecule products. You’ll also work closely within the CMC and project teams under Agile management to identify requirements and constraints of our product in order to define a work plan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions.
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.
- 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.
- 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.
Nice To Haves
- A scientific track record or working knowledge in continuous processing, catalysis, biocatalysis and/or high throughput experimentation desirable.
- Experience with salt/crystalline form selection preferred.
- Experience with oligonucleotide chemistry is a plus.
Responsibilities
- 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.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
- Company match dollar-for-dollar up to 6% on eligible 401(k) contributions.
- Long-term stock incentives.
- ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO.
- Paid holidays.
- Company-wide shutdowns.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
