Director, Process Chemistry
About the position
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 and ASO 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’ll help define product requirements, anticipate challenges, and co-create practical, creative solutions that accelerate progress for patients in urgent need.
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.
Requirements
• Advanced degree or commensurate experience equivalent in Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum of 12 years of industry experience in CMC specifically for small molecule drug substance.
• 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.
• 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.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Nice-to-haves
• A scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high throughput experimentation desirable.
• Experience with salt/crystalline form selection preferred.
• Experience with oligonucleotide chemistry is a plus
Benefits
• At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
• To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
Apply tot his job
Apply To this Job
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 and ASO 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’ll help define product requirements, anticipate challenges, and co-create practical, creative solutions that accelerate progress for patients in urgent need.
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.
Requirements
• Advanced degree or commensurate experience equivalent in Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum of 12 years of industry experience in CMC specifically for small molecule drug substance.
• 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.
• 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.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
Nice-to-haves
• A scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high throughput experimentation desirable.
• Experience with salt/crystalline form selection preferred.
• Experience with oligonucleotide chemistry is a plus
Benefits
• At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
• To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
Apply tot his job
Apply To this Job