Principal Scientist, Process Chemistry

Openkrill; United States; Remote; USD 165,000 - 185,000; Full time

Benefits offered by this job

Health insurance

Dental & Vision

Life insurance

AD&D

Discretionary bonus

401(k) match

Stock options

PTO & holidays

Job summary

Praxis Precision Medicines is seeking a Principal Scientist in Process Chemistry to lead drug substance activities for multiple projects, guiding design, development and scale-up from lab to pilot plant in a fast-paced, Agile environment.

The role requires 5+ years in CMC for small molecules, expertise in GMP, CRO/CMO partnerships, and data packages for regulatory submissions, with remote work and travel as needed. Excellent collaboration and leadership are essential.

Qualifications

• Advanced degree or commensurate experience in Organic Chemistry, Pharmaceutical Sciences, Engineering, or related discipline.
• Minimum of 5+ years of industry experience in CMC specifically for small molecule drug substance.
• Experience with third-party CRO/CMO partners and associated service providers.
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.
• Experience with salt/crystalline form selection; oligonucleotide chemistry is a plus.

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 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.
• Works closely with formulations, analytical, operations, engineering and quality to deliver clinical and commercial drug substance.
• Identifies and leads external CRO/CDMO organizations to achieve deliverables.
• Analyzes external data to drive synthetic experimental plans at CROs and CDMOs.
• Authors or co-authors regulatory submissions.
• Defines manufacturing strategy and GMP requirements and issue resolution.
• Assesses new trends in process development, quality and manufacturing for Praxis products.
• Manages quarterly budgeting of drug substance activities.
• Contributes to inventions that strengthen Praxis IP.

Skills

Process Chemistry Leadership

Continuous processing

CRO/CMO collaboration

Agile environment

Interpersonal communication

Education

Advanced degree in Organic 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

We’re seeking a Principal Scientistin Process Chemistry to lead drug substance activities for one or more projects within Praxis’ portfolio to support clinical and commercial supply. Apply your knowledge to design products & processes to support clinical phase testing and then mature them through development to commercial supply. You are a key leader in the development of drug substance processes for our small molecule products. You’ll also work closely within the CMC and project teams under Agile management to identify requirements and constraints of our product in order to define a work plan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions.

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 which add value to Praxis and its patients while strengthening our intellectual property position.

Qualifications and Key Success Factors

• Advanced degree or commensurate experience equivalent in Organic Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum of 5+ years of industry experience in CMC specifically for small molecule drug substance.
• A scientific track record or working knowledge in continuous processing, catalysis, biocatalysis 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.
• 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.
• 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.

Compensation & 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 in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.Annualized Base Salary$165,000-$185,000 USD

Compensation & 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!

Company Overview

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.