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Role Description

This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The ideal candidate for this role is experienced in working closely with Contract Development and Manufacturing Organizations (CDMOs) that provide small molecule drug substance and drug product services to the pharmaceutical industry. Working closely with Praxis’ CDMO network, the individual will use his or her knowledge of analytical method development, qualification, validation, and testing to support analytical projects across the portfolio. Strong collaboration with Drug Substance/Drug Product scientists, engineers, Quality and manufacturing will be needed to ensure our products and processes are efficient and well-controlled.

Primary Responsibilities

• Support analytical deliverables of the CMC programs while working in conjunction with CMC team members and functional leads.
• Manage analytical testing in our external network, especially as it relates to GMP drug substances and drug products.
• Review raw data, calculations, method validation documents, and stability reports.
• Author analytical methods, CoAs, and reports.
• Document, implement, and monitor change controls.
• Ensure that analytical documentation (protocols, reports, methods, COAs, change controls, etc.) are added contemporaneously to Praxis’ document management system.
• Oversee and coordinate CMC stability and reference standard programs.
• Directly monitor our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve efficiency.
• Support 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.
• Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team.

Qualifications

• Bachelor’s degree in Analytical Chemistry or related discipline with 10+ years of industry experience; Master’s degree or equivalent a plus.
• Industry experience in Analytical Development specifically for small molecule drug substance as well as solid and liquid oral drug products (e.g., capsules, tablets, oral suspensions) is required.
• Strong attention to detail along with the ability to perform meticulous data review and data transcription review.
• 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 CDMO partners and associated service providers to ensure the company’s objectives are achieved.
• 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.

Requirements

• 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.
• Comfort with screen work, basic hand coordination, and focus.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Benefits

• 99% of the premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Extremely flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.
• Join a phenomenal crew of colleagues who are smart, engaged, and inspiring.

Company Description

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.

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.