Principal Scientist, Analytical Development

United StatesRemotelead

Other

0 views0 saves0 applied

Apply Now

Quick Summary

Overview

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity The Principal Scientist, Analytical Development,

Technical Tools

Other

The Principal Scientist, Analytical Development, will play a critical role in advancing Praxis’ clinical pipeline by leading analytical development strategies for small molecule drug substances and drug products across our virtual network of CMOs and external partners.

This is a highly cross-functional, hands-on leadership role responsible for developing, qualifying, validating, transferring, and supporting GMP analytical methods and control strategies throughout the product lifecycle. The individual will provide deep technical expertise in analytical chemistry and small molecule development, with a strong understanding of phase-appropriate analytical strategies from early development through drug approval.

The successful candidate will partner closely with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to establish robust, scalable, and compliant analytical control strategies. This individual will help build an agile, forward-looking analytical development function capable of supporting innovative CNS therapies with scientific rigor, urgency, and a focus on patient impact.

Responsibilities

~1 min read

→Serve as the Analytical Lead for small molecule CMC programs, providing technical leadership across drug substance and drug product analytical development activities.
→Lead analytical method development, qualification, validation, transfer, and GMP testing activities across internal teams and external CRO/CMO partners.
→Develop and implement phase-appropriate analytical control strategies, specifications, and stability programs for small molecule drug substances and drug products.
→Provide hands-on technical leadership for analytical troubleshooting, data interpretation, impurity characterization, method lifecycle management, and analytical investigations.
→Review and approve analytical documentation, including methods, validation and qualification reports, stability reports, specifications, certificates of analysis, and other CMC documentation.
→Direct and manage external CRO/CMO analytical partners to ensure high-quality execution, effective communication, timely delivery, and continuous technical and operational improvement.
→Provide strategic and technical expertise to support regulatory submissions, commercialization readiness, and ongoing product lifecycle management while partnering cross-functionally to strengthen scalable analytical processes and practices.

Requirements

~2 min read

Advanced degree (PhD preferred; Master’s with significant industry experience considered) in Analytical Chemistry or a related discipline with 8+ years of relevant industry experience.
Strong industry experience in analytical development for small molecule drug substances and drug products, including solid oral dosage forms.
Deep knowledge of analytical techniques and strategies relevant to small molecules, including impurity characterization, assay and purity testing, stability assessment, and GMP analytical control strategies.
Strong understanding of US and EU cGMP requirements and analytical best practices for drug substance and drug product development.
Experience supporting CMC development across multiple stages, including analytical development, regulatory submissions, method validation and transfer, and commercialization activities.
Experience managing external CRO/CMO analytical networks and building productive technical partnerships.
Strong working knowledge of quality systems, reference standards, stability programs, specifications, and compendial testing requirements.

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 in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Annualized Base Salary

$170,000—$190,000 USD

What We Offer

~2 min read

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
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 careers@praxismedicines.com.

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.