Director, Process Chemistry

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 215,000 - 235,000; Full time

Job summary

Praxis Precision Medicines, Inc. in Boston is seeking a Director of Process Chemistry to lead drug substance activities across programs, driving clinical and commercial readiness.

You will design and mature processes from lab to pilot plant, collaborating with CMC, formulations, analytical, operations and quality to deliver regulatory-ready drug substance. This role requires a strong track record in small-molecule CMC, leadership in process development, and a hands-on, collaborative approach to

Qualifications

• Advanced degree or commensurate experience equivalent in Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum 12 years of industry experience in CMC specifically for small molecule drug substance.
• Experience with salt/crystalline form selection preferred.

Responsibilities

• Leads the Process Chemistry Research and Development for one or more projects from early to late phase within Praxis.
• Designs both early phase and late-phase/commercial drug substance process and then leads their demonstration from lab to pilot plant.
• Provides chemistry and technical leadership throughout the lifecycle.
• Participates/leads activities to identify final API forms for pharmaceutical development.
• Working closely with formulations, analytical, operations, engineering and quality, integrated into the CMC team for clinical and commercial delivery.
• Identify, collaborate and lead external CRO, and CDMO organizations to achieve deliverables.
• Analyze external data to drive synthetic experimental plans at CROs and CDMO.
• Authoring or co-authoring of regulatory submissions.
• Define manufacturing strategy and execution, including GMP requirements.
• Manage quarterly budgeting of drug substance relevant activities.
• Contributor to inventions that add value to Praxis and its patients while strengthening IP.

Skills

Process Development Leadership

Small Molecule CMC

Continuous Processing

Biocatalysis/Catalysis

High Throughput Experimentation

cGMP Knowledge

External Partner Management

Project Management

Regulatory Submissions

Education

Advanced degree in Chemistry or related field

Job description

Location

This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

As Director of Process Chemistry, you will take the lead on drug substance activities for one or more projects within Praxis’ portfolio of small molecule programs to drive forward both clinical and commercial readiness.You’ll design products & processes that support clinical phase testing and then mature those processes through development to Commercial supply.Working intimately within the CMC and project teams under Agile management you’ll identify requirements and constraints of our product to define a workplan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions.

This role is ideal for someone who thrives in a fast-moving, collaborative environment, where science meets ownership.You’llhelp define product requirements,anticipatechallenges, and co-create practical, creative solutions that accelerate progress for patients in urgent need.

Primary Responsibilities

• Leads the Process Chemistry Research and Development for one or more projects from early to late phase within Praxis.
• Designs both early phase and late-phase/commercial drug substance process and then leads their demonstration from lab to pilot plant.
• Provides chemistry and technical leadership throughout the lifecycle
• Participates/leads activities to identify final API forms for pharmaceutical development.
• Working closely with formulations, analytical, operations, engineering and quality, expectation to be integrated into the overall CMC team responsible for delivery of clinical and commercial drug substance to Praxis programs.
• Identify, collaborate and lead external CRO, and CDMO organization(s) to achieve deliverables.
• Analyze external experimental data to drive synthetic experimental plans at CROs and CDMO.
• Authoring or co-authoring of regulatory submissions.
• Define manufacturing strategy and execution, including GMP requirements and issue resolution.
• Assessment and application of new trends and concerns in process development, quality and manufacturing to Praxis’ products.
• Manage quarterly budgeting of drug substance relevant activities.
• Contributor to inventions that add value to Praxis and its patients while strengthening our intellectual property position.

Qualifications and Key Success Factors

• Advanced degree orcommensurateexperience equivalent in Chemistry, Pharmaceutical Sciences,Engineeringor related discipline.
• Minimum of 12 years of industry experience in CMC specifically for small molecule drug substance.
• A scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high throughput experimentation desirable.
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.
• Strong knowledge of CMC development across all phases of drug development from initial regulatory filings through registration, validation and launch.
• Experience in working with third-party CRO / CMO partners and associated service providers to develop and manufacturing pharmaceutical products.
• Experience with salt/crystalline form selection preferred.
• Experience with oligonucleotide chemistry is a plus
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
• Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.
• Highly organized and detail-oriented with a passion to deliver quality results.

$215,000 - $235,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.