Principal Scientist, Process Chemistry

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee Process Chemistry Research and Development for one or multiple projects from inception to completion.

• Create both early-phase and late-phase/commercial drug substance processes and spearhead their demonstration from the laboratory to the pilot plant stage.

• Provide technical and chemistry leadership throughout the entire product lifecycle.

• Engage in or lead initiatives to determine the final API forms for pharmaceutical development.

• Collaborate with formulations, analytical, operations, engineering, and quality teams within the CMC team to ensure the delivery of clinical and commercial drug substances.

• Identify, collaborate with, and lead external CRO and CDMO organizations to meet project deliverables.

• Evaluate external experimental data to inform synthetic experimental plans at CROs and CDMOs.

• Prepare or co-prepare regulatory submissions.

• Establish manufacturing strategies and oversee execution, including GMP requirements and issue resolution.

• Evaluate and implement new trends and concerns in process development, quality, and manufacturing.

• Manage the quarterly budget for drug-substance-related activities.

• Contribute to innovations that enhance the value to Praxis and patients while reinforcing intellectual property.

⛳️ Requirements

• Advanced degree or equivalent experience in Organic Chemistry, Pharmaceutical Sciences, Engineering, or a related field.

• A minimum of 5+ years of industry experience in CMC, particularly concerning small-molecule drug substances.

• A scientific background or familiarity with continuous processing, catalysis, biocatalysis, and/or high-throughput experimentation is desirable.

• Strong understanding of US and EU cGMP standards and best practices for drug substances and drug products.

• Comprehensive knowledge of CMC development throughout all drug development phases, from initial regulatory submissions through to registration, validation, and launch.

• Experience collaborating with third-party CRO/CMO partners and associated service providers in the development and manufacturing of pharmaceutical products.

• Preferred experience with salt/crystalline form selection.

• Familiarity with oligonucleotide chemistry is a plus.

• A strong sense of intellectual curiosity, innovation, creative problem-solving skills, and an entrepreneurial mindset.

• Capability to excel in a dynamic environment.

• Exceptional interpersonal and communication skills.

• Ability to build trusted relationships and promote diversity.

• Highly organized and detail-oriented, with a commitment to delivering quality results.

🏝️ Benefits

• 99% of medical, dental, and vision insurance premiums covered.

• Company-sponsored life insurance.

• Company-funded AD&D benefits.

• Disability benefits provided.

• Optional plans to customize coverage.

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions.

• Long-term stock incentives available.

• Employee Stock Purchase Plan (ESPP) offered.

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.