Director, Process Chemistry

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🔥 1 minute ago

🇺🇸 United States – Remote

💵 $210k - $230k / year

⏰ Full Time

🔴 Lead

👔 Director

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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 drug substance activities for one or more small-molecule programs from clinical development through commercial readiness • Lead process chemistry research and development for projects from early to late phase • Design early-phase and late-phase/commercial drug substance processes and lead demonstration from laboratory to pilot plant • Provide chemistry and technical leadership throughout the product lifecycle • Lead or participate in identifying final API forms for pharmaceutical development • Collaborate with formulation, analytical, operations, engineering, and quality teams within the CMC organization • 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 for drug-substance-related activities • Contribute to inventions that strengthen Praxis’ intellectual property position and add value for patients

🎯 Requirements

• Advanced degree or commensurate equivalent experience in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline • Minimum 12 years of industry experience in CMC specifically for small-molecule drug substance • Strong knowledge of US and EU cGMP requirements and best practices for drug substances and drug products • Strong knowledge of CMC development across all phases, from initial regulatory filings through registration, validation, and launch • Experience working with third-party CRO/CMO partners and service providers to develop and manufacture pharmaceutical products • Scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high-throughput experimentation is desirable • Experience with salt/crystalline form selection is preferred • Experience with oligonucleotide chemistry is a plus • High intellectual curiosity, innovation, creative problem solving, entrepreneurial spirit, and ability to thrive in an agile environment • Excellent interpersonal and communication skills, with ability to develop trusted relationships and encourage diversity • Highly organized and detail-oriented, with passion for delivering quality results • Flexibility and willingness to travel as needed

🏖️ Benefits

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