Principal Scientist, Process Chemistry

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

📋 Description

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

• Create processes for early-phase and late-phase/commercial drug substances and manage the transition from laboratory to pilot plant.

• Provide leadership in chemistry and technical aspects throughout the product lifecycle.

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

• Work collaboratively with formulations, analytical, operations, engineering, and quality teams as part of the CMC team.

• Identify, partner with, and guide external CRO and CDMO organizations to meet project deliverables.

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

• Write or co-write regulatory submissions.

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

• Monitor and implement new trends and challenges in process development, quality, and manufacturing.

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

• Contribute to innovations that enhance Praxis's value and strengthen its intellectual property portfolio.

⛳️ Requirements

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

• A minimum of 5+ years of industry experience within CMC specifically focused on small molecule drug substances.

• A proven scientific track record or familiarity with continuous processing, catalysis, biocatalysis, and/or high throughput experimentation is desirable.

• In-depth knowledge of US and EU cGMP requirements and best practices pertaining to drug substances and drug products.

• Comprehensive understanding of CMC development across all stages of drug development, from initial regulatory submissions to registration, validation, and launch.

• Experience collaborating with third-party CRO/CMO partners and relevant service providers for the development and manufacture of pharmaceutical products.

• Preferred experience in salt/crystalline form selection.

• Familiarity with oligonucleotide chemistry is advantageous.

• Ability to thrive in an agile work environment.

• Exceptional interpersonal and communication skills.

• Highly organized with a keen attention to detail.

• Regular use of computers/devices/office equipment, effective communication, occasional movement, screen work, basic hand coordination, and focus are required.

• Openness and flexibility to travel as needed.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-funded life insurance, AD&D, and disability benefits.

• Optional plans to customize coverage.

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

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous Paid Time Off (PTO).

• Paid holidays.

• Company-wide shutdowns.

• Flexibility for remote work.

• Travel flexibility as required.