Principal Scientist, Analytical Development, Oligo and Small Molecule
Praxis Precision Medicines, Inc.
17 days ago
Remote friendly (Boston, MA)
United States
Operations
Position Summary
- Principal Scientist, Analytical Development role translating analytical strategies from development into manufacturing across a virtual network of CMOs and external partners.
- Focus on oligonucleotide-based therapeutics; also supports small molecule programs.
- Hands-on, cross-functional leadership partnering with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing.
Primary Responsibilities
- Serve as Analytical Lead across CMC programs (primary responsibility for oligonucleotide analytical development; support for small molecule).
- Lead analytical method development, qualification, validation, transfer, and GMP testing (internal and external partners).
- Drive troubleshooting, data interpretation, method lifecycle management; review analytical documentation (validation reports, stability reports, specifications, CoAs).
- Design phase-appropriate analytical control strategies, specifications, and stability programs for drug substances and drug products.
- Direct and manage CRO/CMO analytical partners; ensure high-quality execution and continuous improvement.
- Collaborate to strengthen CMC operations and establish scalable analytical practices.
- Support regulatory filings, commercialization readiness, and product lifecycle management.
Qualifications
- PhD preferred (Master’s considered with significant industry experience); 5–7+ years industry experience in analytical chemistry.
- Strong experience in analytical development for oligonucleotide drug substances and/or drug products (required).
- Experience with small molecule drug substances and solid oral dosage forms (strongly preferred).
- Deep knowledge of oligonucleotide impurity characterization, stability assessment, and GMP control strategies.
- Strong US/EU cGMP knowledge and analytical best practices.
- Experience across multiple CMC stages, including regulatory submissions, validation, and commercialization.
- Experience managing CRO/CMO analytical networks.
- Working knowledge of quality systems, reference standards, stability programs, and compendial testing.
Compensation & Benefits
- Annualized base salary: $165,000–$185,000 USD; plus comprehensive benefits package including 99% premium coverage for medical/dental/vision, 401(k) match up to 6%, long-term incentives/ESPP, quarterly bonus, flexible wellness benefit, and generous PTO.
Application Instructions
- Remote with flexibility to travel as needed.
- Principal Scientist, Analytical Development role translating analytical strategies from development into manufacturing across a virtual network of CMOs and external partners.
- Focus on oligonucleotide-based therapeutics; also supports small molecule programs.
- Hands-on, cross-functional leadership partnering with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing.
Primary Responsibilities
- Serve as Analytical Lead across CMC programs (primary responsibility for oligonucleotide analytical development; support for small molecule).
- Lead analytical method development, qualification, validation, transfer, and GMP testing (internal and external partners).
- Drive troubleshooting, data interpretation, method lifecycle management; review analytical documentation (validation reports, stability reports, specifications, CoAs).
- Design phase-appropriate analytical control strategies, specifications, and stability programs for drug substances and drug products.
- Direct and manage CRO/CMO analytical partners; ensure high-quality execution and continuous improvement.
- Collaborate to strengthen CMC operations and establish scalable analytical practices.
- Support regulatory filings, commercialization readiness, and product lifecycle management.
Qualifications
- PhD preferred (Master’s considered with significant industry experience); 5–7+ years industry experience in analytical chemistry.
- Strong experience in analytical development for oligonucleotide drug substances and/or drug products (required).
- Experience with small molecule drug substances and solid oral dosage forms (strongly preferred).
- Deep knowledge of oligonucleotide impurity characterization, stability assessment, and GMP control strategies.
- Strong US/EU cGMP knowledge and analytical best practices.
- Experience across multiple CMC stages, including regulatory submissions, validation, and commercialization.
- Experience managing CRO/CMO analytical networks.
- Working knowledge of quality systems, reference standards, stability programs, and compendial testing.
Compensation & Benefits
- Annualized base salary: $165,000–$185,000 USD; plus comprehensive benefits package including 99% premium coverage for medical/dental/vision, 401(k) match up to 6%, long-term incentives/ESPP, quarterly bonus, flexible wellness benefit, and generous PTO.
Application Instructions
- Remote with flexibility to travel as needed.