Director, Process Chemistry

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

📋 Description

• Oversee drug substance initiatives for one or more small-molecule programs from clinical development through to commercial readiness.

• Direct process chemistry research and development for projects spanning from early to late phases.

• Develop early-phase and late-phase/commercial drug substance processes and guide their transition from laboratory to pilot plant.

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

• Lead or engage in determining final API forms for pharmaceutical development.

• Work collaboratively with formulation, analytical, operations, engineering, and quality teams within the CMC organization.

• Identify, collaborate with, and manage external CRO and CDMO organizations to ensure successful deliverables.

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

• Write or co-write regulatory submissions.

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

• Evaluate and apply new trends and challenges in process development, quality, and manufacturing.

• Manage quarterly budgets pertaining to drug-substance-related activities.

• Contribute to innovations that enhance Praxis’ intellectual property standing and provide value for patients.

⛳️ Requirements

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

• A minimum of 12 years of industry experience in CMC specifically related to small-molecule drug substances.

• Comprehensive knowledge of US and EU cGMP requirements and best practices for drug substances and drug products.

• Extensive understanding of CMC development across all phases, from initial regulatory submissions through registration, validation, and launch.

• Proven experience working with third-party CRO/CMO partners and service providers for the development and manufacturing of pharmaceutical products.

• Scientific background or working knowledge in continuous processing, biocatalysis, catalysis, and/or high-throughput experimentation is advantageous.

• Experience with salt/crystalline form selection is preferred.

• Familiarity with oligonucleotide chemistry is a plus.

• High intellectual curiosity, innovative mindset, creative problem-solving skills, entrepreneurial spirit, and the ability to excel in a dynamic environment.

• Outstanding interpersonal and communication skills, with the ability to build trusted relationships and promote diversity.

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

• Willingness to travel as required.

🏝️ Benefits

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

• Life insurance provided by the company.

• AD&D benefits included.

• Disability benefits available.

• Optional plans to customize coverage.

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

• Long-term stock incentives offered.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonus opportunities.

• Flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns observed.