Director, Process Chemistry

Job not on LinkedIn

🕒 August 4

🇺🇸 United States – Remote

💵 $215k - $235k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 37%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 early development through commercial readiness • Design early-phase and late-phase/commercial drug substance processes and lead their demonstration from laboratory to pilot plant • Lead Process Chemistry research and development across project phases • Provide chemistry and technical leadership throughout the product lifecycle • Participate in or lead identification of final API forms for pharmaceutical development • Collaborate with formulation, analytical, operations, engineering and quality teams on clinical and commercial drug substance delivery • 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 activities • Contribute to inventions that strengthen Praxis’ 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 • Scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, 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 • High level of intellectual curiosity, innovation, creative problem solving and entrepreneurial spirit; ability to thrive in an agile environment • Excellent interpersonal and communication skills, with ability to develop important relationships that include trust and encourage diversity • Highly organized and detail-oriented with a passion to deliver quality results

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • 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