Senior Process Engineer, Drug Substance

Job not on LinkedIn

🕒 October 9

🇺🇸 United States – Remote

💵 $110k - $125k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

🦅 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

• Work closely with Contract Manufacturing Organizations (CMOs) to support and validate processes for manufacturing small molecule Active Pharmaceutical Ingredients (APIs) • Support future commercial production and help ensure appropriate supply levels • Maintain day-to-day communications with CMOs • Contribute to knowledge transfer activities between Praxis and CMOs • Understand written chemical synthesis processes from lab partners • Translate synthesis processes into industrial execution instructions by authoring scale-up spreadsheets and process manuals • Gather, analyze, and archive large data packages for regulatory filings • Review CMO and lab partner documentation, including instructions, procedures, batch records, non-conformances, in-process controls, certificates of analysis, and developmental reports • Work alongside Quality Assurance to ensure regulations and standards are followed by third parties • Adhere to industry guidelines, standards, laws, and cGMPs • Identify and escalate process risks and support mitigation plans • Travel to and participate in person-in-plant activities at CMOs in the US and worldwide

🎯 Requirements

• Bachelor’s or advanced degree in chemical engineering or another relevant engineering field; MS or equivalent is a plus • Pharmaceutical or fine chemical industry experience required • 4–8 years of applied experience in CMO management, chemical manufacturing, or comparable positions handling diverse chemical syntheses in laboratory and manufacturing environments • Experience reviewing manufacturing and executed batch records, operating procedures, non-conformances, and change controls • Experience supporting business partner relationships • Ability to understand written chemical synthesis processes and translate them into industrial execution instructions • Ability to use technologies and applications to gather, analyze, and archive large data packages supporting regulatory filings • Knowledge of cGMPs, industry guidelines, standards, and laws • Excellent written and visual communication skills • Ability to build relationships internally and externally • Self-motivated and able to contribute to a productive, collaborative team environment • Highly organized and detail-oriented • Willingness and flexibility to travel as needed, including in-person in-plant activities at CMOs in the US and worldwide • Comfort with regular computer/device use, screen work, basic hand coordination, clear communication, and focus

🏖️ 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 • Reasonable accommodations for individuals with disabilities