- Location
- United States - Remote
- Workplace
- Remote
- Department
- CMC
- Seniority
- Lead
- Education
- PhD
- Source
- Greenhouse
Description
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
Responsible for translating the processes and products for Praxis’ clinical and commercial pipeline from the laboratory to the manufacturing environment in our virtual development and CMO network. The individual will use his or her 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 will be needed to ensure our product and processes are efficient and well controlled. S/he will be a leader contributing to ensuring the analytical function is agile and at the forefront in the industry. This mission-critical role will deliver to product teams within CMC to realize Praxis’ pipeline of innovative medicines for neurological disease.
Primary Responsibilities
- Involved in all analytical deliverables with CMC program while acting as Analytical lead, including management and execution of analytical testing and for the Analytical Development team and our external network, especially as it relates to method development, validation and GMP testing. This includes technical troubleshooting, data interpretation, reviewing method validation documents, authoring CoA-s, stability reports.
- Direct management of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve on efficiency.
- Leading the design and development of phase-appropriate quality control strategies, specifications, and stability studies for drug substance and drug product.
- Contribute to the overall CMC team in terms of execution but also development of our CMC operations function, process improvement.
- Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team.
Qualifications and Key Success Factors
- Advanced degree (PhD or Masters degree with related experience) in Analytical Chemistry or related discipline with 5-7 years of industry experience. Preferred with biopharmaceutical innovator or CMO.
- 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.
- 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. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Compensation & 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. We also provide company-paid life insurance, AD&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!
To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
Company Overview
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. 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. 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 & 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
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