Principal Scientist, Analytical Development United States - Remote

Praxis Precision Medicines, Inc.; United States; Remote; USD 170,000 - 190,000; Full time

Job summary

Praxis Precision Medicines, Inc. seeks a Principal Scientist in Analytical Development focused on oligonucleotide therapeutics with secondary support for small molecules.

Remote work in the United States is offered, with travel as needed, to advance analytical strategies from development through manufacturing within a virtual network of partners. The candidate will lead method development, qualification, validation, transfer and GMP testing, shaping robust analytical control strategies and

Qualifications

• Advanced degree in Analytical Chemistry or related discipline with 5–7+ years of industry experience.
• Strong experience in analytical development for oligonucleotide drug substances/products.
• Experience supporting small molecule drug substances and solid oral dosage forms preferred.
• Deep knowledge of analytical techniques relevant to oligonucleotides, impurity characterization, stability assessment, and GMP control strategies.
• Strong understanding of US/EU cGMP requirements and analytical best practices for drug substances/products.
• Experience supporting CMC development across regulatory submissions, validation, and commercialization.
• Experience managing external CRO/CMO analytical networks and partnerships.
• Knowledge of quality systems, reference standards, stability programs, and compendial testing requirements.

Responsibilities

• Serve as Analytical Lead across CMC programs with primary responsibility for oligonucleotide analytical development and support for small molecule programs.
• Lead analytical method development, qualification, validation, transfer, and GMP testing across internal teams and external partners.
• Drive troubleshooting, data interpretation, method lifecycle management, and review of validation/stability/CoA documents.
• Design and implement phase-appropriate analytical control strategies, specifications, and stability programs for oligonucleotide and small molecule substances/products.
• Direct and manage CRO/CMO analytical partners to ensure high-quality execution and communication.
• Collaborate across functions to strengthen CMC operations and scalable practices within the analytical function.
• Contribute to regulatory filings, commercialization readiness, and lifecycle management.

Skills

Analytical development

Oligonucleotide analytics

GMP testing

Method development

CRO/CMO management

Education

PhD in Analytical Chemistry

Masters with significant industry experience

Tools

HPLC

LC-MS

Job description

Principal Scientist, Analytical Development, Oligo and Small Molecule

United States - Remote

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

Position Summary

• The Principal Scientist, Analytical Development will play a critical role in advancing Praxis’ clinical and commercial pipeline by translating analytical strategies from development into manufacturing across our virtual network of CMOs and external partners.
• This role is particularly focused on advancing oligonucleotide-based therapeutics, while also supporting small molecule programs across the portfolio. The individual will bring deep expertise in analytical method development, qualification, validation, troubleshooting, and GMP testing for oligonucleotide drug substances and drug products, with the ability to apply phase-appropriate analytical strategies across multiple modalities.
• This is a highly cross-functional, hands-on leadership role requiring close partnership with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to ensure robust, scalable, and compliant analytical control strategies. The successful candidate will help shape an agile, forward-looking analytical development function capable of supporting innovative CNS therapies from early development through commercialization.

Primary Responsibilities

• Serve as Analytical Lead across CMC programs, with primary responsibility for oligonucleotide analytical development activities and support for small molecule programs
• Lead analytical method development, qualification, validation, transfer, and GMP testing activities across internal teams and external partners
• Drive technical troubleshooting, data interpretation, method lifecycle management, and review of analytical documentation including validation reports, stability reports, specifications, and CoAs
• Design and implement phase-appropriate analytical control strategies, specifications, and stability programs for oligonucleotide and small molecule drug substances and drug products
• Direct and manage CRO/CMO analytical partners to ensure high-quality execution, strong communication, and continuous operational improvement
• Collaborate cross-functionally to strengthen CMC operations, improve processes, and establish scalable technical and business practices across the analytical function
• Contribute strategic and technical expertise to support regulatory filings, commercialization readiness, and ongoing product lifecycle management

Qualifications and Key Success Factors

• Advanced degree (PhD preferred;Master’swith significant industry experience considered) in Analytical Chemistry or related discipline with 5–7+ years of industry experience
• Strong industry experience in analytical development for oligonucleotide drug substances and/or drug products required
• Experience supporting small molecule drug substances and solid oral dosage forms strongly preferred
• Deep knowledge of analytical techniques relevant to oligonucleotides, including impurity characterization, stability assessment, and GMP 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 of development, including regulatory submissions, validation, 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, and compendial testing requirements

Key Success Factors

• Brings deep technical curiosity and strong scientific judgment, particularly in emerging oligonucleotide modalities
• Operates with high ownership and accountability in fast-moving, ambiguous environments
• Balances strategic thinking with hands‑on execution and problem solving
• Communicates clearly and collaborates effectively across functions and external partners
• Continuously challenges assumptions and looks for smarter, more scalable ways of working
• Thrives in agile environments that require adaptability, rigor, and urgency
• Highly organized, detail‑oriented, and motivated by delivering high‑quality outcomes that advance therapies for patients

$170,000 - $190,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and

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.