Description

Location: &nbsp;This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity We’re&nbsp;seeking a&nbsp;Principal Scientist in&nbsp;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 &amp; 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 and ASO products. &nbsp;You’ll&nbsp;also work closely within the CMC and project teams under Agile management to&nbsp;identify&nbsp;requirements and constraints of our product&nbsp;in order to&nbsp;define a work plan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions.&nbsp; Primary Responsibilities <ul> <li>Leads the Process Chemistry Research and Development for one or more projects from early to late phase within Praxis.&nbsp;</li> <li>Designs both early phase and&nbsp;late-phase/commercial drug substance process and then leads their demonstration from lab to pilot plant.&nbsp;</li> <li>Provides chemistry and technical leadership throughout the lifecycle&nbsp;</li> <li>Participates/leads activities to&nbsp;identify&nbsp;final API forms for pharmaceutical development.&nbsp;</li> <li>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&nbsp;substance&nbsp;to Praxis programs.&nbsp;</li> <li>Identify,&nbsp;collaborate&nbsp;and lead external CRO, and CDMO organization(s) to achieve deliverables.&nbsp;</li> <li>Analyze external experimental data to drive synthetic experimental plans at CROs and CDMO.&nbsp;</li> <li>Authoring or co-authoring of regulatory submissions.&nbsp;</li> <li>Define manufacturing strategy and execution, including GMP requirements and issue resolution.&nbsp;</li> <li>Assessment and application of&nbsp;new trends&nbsp;and concerns in process development,&nbsp;quality&nbsp;and manufacturing to Praxis’ products.&nbsp;</li> <li>Manage quarterly budgeting of drug substance relevant activities.&nbsp;</li> <li>Contributor&nbsp;to inventions which add value to Praxis and its patients while strengthening our intellectual property position.&nbsp;</li> </ul> Qualifications and Key Success Factors <ul> <li>Advanced degree or&nbsp;commensurate&nbsp;experience equivalent in&nbsp;Organic&nbsp;Chemistry, Pharmaceutical Sciences,&nbsp;Engineering&nbsp;or related discipline.&nbsp;</li> <li>Minimum of 5+ years of industry experience in CMC specifically for small molecule drug&nbsp;substance.&nbsp;</li> <li>A scientific&nbsp;track record&nbsp;or working knowledge in continuous processing, catalysis,&nbsp;biocatalysis&nbsp;and/or high throughput experimentation desirable.&nbsp;</li> <li>Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.&nbsp;</li> <li>Strong knowledge of CMC development across all phases of drug development from&nbsp;initial&nbsp;regulatory filings through registration,&nbsp;validation&nbsp;and launch.&nbsp;</li> <li>Experience in&nbsp;working with third-party CRO / CMO partners and associated service providers to develop and&nbsp;manufacturing&nbsp;pharmaceutical products.&nbsp;</li> <li>Experience with salt/crystalline form&nbsp;selection&nbsp;preferred.&nbsp;</li> <li>Experience with oligonucleotide chemistry is a plus.&nbsp;</li> <li>Demonstrates&nbsp;a high level&nbsp;of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.&nbsp;</li> <li>Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all&nbsp;its&nbsp;forms.&nbsp;</li> <li>Highly organized and detail-oriented with a passion to deliver quality results.&nbsp;</li> <li>The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. &nbsp;You'll&nbsp;need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.&nbsp;</li> </ul> Compensation &amp; Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans. &nbsp;We also provide company-paid life insurance, AD&amp;D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!&nbsp; To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.&nbsp; Final salary range may be modified commensurate with job level, education, and experience.<div class="content-pay-transparency"><div class="pay-input"><div class="title">Annualized Base Salary</div><div class="pay-range">$165,000&mdash;$185,000 USD</div></div></div><div class="content-conclusion">Company Overview&nbsp; Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.&nbsp; At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.&nbsp; Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity &amp; Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to <a href="mailto:careers@praxismedicines.com">careers@praxismedicines.com</a>. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.</div>

Principal Scientist, Process Chemistry

Description

Praxis Precision Medicines

Pipeline