Vp Analytical Development Small Molecule Jobs (NOW HIRING)

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's with 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