Principal Scientist, Analytical Development

OpenKrill; United States; Remote; USD 170,000 - 190,000; Full time

Benefits offered by this job

Discretionary quarterly bonus

401(k) matching

Long‑term stock incentives and ESPP

Flexible wellness benefit

Generous PTO and paid holidays

Job summary

Praxis Precision Medicines seeks a Principal Scientist, Analytical Development to steer analytical strategies for small molecule drug substances and products. You will lead method development, qualification, validation, transfer, and GMP testing with internal teams and external partners.

The role requires deep analytical chemistry expertise, with phase-appropriate strategies spanning early development to approval.

Qualifications

• PhD (preferred) in Analytical Chemistry or related field with 8+ years in industry.
• Strong analytical development experience for small molecules and drug products.
• Knowledge of US/EU cGMP requirements and analytical strategies.

Responsibilities

• Lead analytical development, qualification, validation, transfer, and GMP testing across teams and CROs/CMOs.
• Develop phase-appropriate control strategies, specifications, and stability programs for small molecules.
• Review and approve analytical docs including validation reports, stability reports, and COAs.
• Drive external partner management to ensure quality, on-time delivery, and continuous improvement.
• Support regulatory submissions and lifecycle management with cross-functional collaboration.

Skills

Analytical Chemistry

Small Molecule Development

Analytical Method Development

GMP/CMC Knowledge

Regulatory Submissions

External CRO/CMO Management

Education

PhD in Analytical Chemistry

Master’s with significant industry experience

Tools

HPLC/LC-MS

Impurity Characterization

Stability Programs

Quality Systems

Job description

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

The Opportunity

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.

Primary Responsibilities

• 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.

Qualifications and Key Success Factors

• 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.

Key Success Factors

• Brings deep technical curiosity and strong scientific judgment in small molecule analytical development.
• Operates with high ownership and accountability in fast-moving, ambiguous environments.
• Balances strategic thinking with hands-on execution, troubleshooting, and problem solving.
• Communicates clearly and collaborates effectively across Drug Substance, Drug Product, Quality, Regulatory, Manufacturing, and external partners.
• Continuously challenges assumptions and looks for smarter, more scalable ways of working.
• Thrives in an agile environment that requires adaptability, rigor, urgency, and strong follow-through.
• Is highly organized, detail-oriented, and motivated by delivering high-quality outcomes that advance therapies for patients.

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 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

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!

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 & InclusionGuided 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 authe