Principal Scientist, Process Chemistry

Job not on LinkedIn

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $165k - $185k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

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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 demonstration from lab to pilot plant • Provide chemistry and technical leadership throughout the product lifecycle • Participate in or lead activities to identify final API forms for pharmaceutical development • Collaborate with formulations, analytical, operations, engineering, and quality teams as part of the CMC team • 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-related activities • Contribute to inventions that add value to Praxis and strengthen its intellectual property position

🎯 Requirements

• 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 • 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 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 • Ability to work in an agile environment • Excellent interpersonal and communication skills • Highly organized and detail-oriented • Regular computer/device/office equipment use, clear communication, occasional movement, screen work, basic hand coordination, and focus • Willingness and flexibility to travel as needed

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance, AD&D, and 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 • Remote work flexibility • Travel flexibility as needed