Principal Scientist, Process Chemistry

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🔥 2 hours ago

🇺🇸 United States – Remote

💵 $165k - $185k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Lead Process Chemistry Research and Development for one or more projects from early to late phase • Design early-phase and late-phase/commercial drug substance processes and lead their demonstration from laboratory to pilot plant • Provide chemistry and technical leadership throughout the product lifecycle • Participate in or lead activities identifying final API forms for pharmaceutical development • Work with formulations, analytical, operations, engineering and quality teams within the CMC team to deliver clinical and commercial drug substance • Identify, collaborate with and lead external CRO and CDMO organizations to achieve deliverables • Analyze external experimental data to drive synthetic experimental plans at CROs and CDMOs • Author or co-author regulatory submissions • Define manufacturing strategy and execution, including GMP requirements and issue resolution • Assess and apply new trends and concerns in process development, quality and manufacturing • Manage quarterly budgeting of drug-substance-relevant activities • Contribute to inventions that add value to Praxis and patients while strengthening intellectual property

🎯 Requirements

• Advanced degree or commensurate experience equivalent in Organic Chemistry, Pharmaceutical Sciences, Engineering or a related discipline • Minimum 5+ years of industry experience in CMC specifically for small-molecule drug substance • 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 for drug substances and drug products • Strong knowledge of CMC development across all drug-development phases, from initial regulatory filings through registration, validation and launch • Experience working with third-party CRO/CMO partners and associated service providers to develop and manufacture pharmaceutical products • Experience with salt/crystalline form selection preferred • Experience with oligonucleotide chemistry is a plus • Intellectual curiosity, innovation, creative problem-solving ability and an entrepreneurial spirit • Ability to thrive in an agile environment • Excellent interpersonal and communication skills • Ability to develop trusted relationships and encourage diversity • Highly organized and detail-oriented, with a passion for delivering quality results

🏖️ Benefits

• 99% of medical, dental and vision insurance premiums paid • Company-paid life insurance • Company-paid AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) match up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns