Senior Process Engineer, Drug Substance

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate closely with Contract Manufacturing Organizations (CMOs) to assist and validate processes for the production of small molecule Active Pharmaceutical Ingredients (APIs).

• Aid in future commercial production while ensuring adequate supply levels.

• Maintain regular communication with CMOs on a daily basis.

• Participate in knowledge transfer initiatives between Praxis and CMOs.

• Comprehend written chemical synthesis processes provided by lab partners.

• Convert synthesis processes into industrial execution directives by creating scale-up spreadsheets and process manuals.

• Collect, analyze, and store extensive data packages for regulatory submissions.

• Examine documentation from CMOs and lab partners, which includes instructions, procedures, batch records, non-conformances, in-process controls, certificates of analysis, and developmental reports.

• Collaborate with Quality Assurance to ensure compliance with regulations and standards imposed on third parties.

• Follow industry guidelines, standards, laws, and cGMPs strictly.

• Identify and escalate process risks while supporting the development of mitigation strategies.

• Travel to and engage in on-site activities at CMOs both in the US and internationally.

⛳️ Requirements

• Bachelor’s or advanced degree in chemical engineering or a related engineering discipline; a Master's degree or equivalent is advantageous.

• Required experience in the pharmaceutical or fine chemical industry.

• 4–8 years of relevant experience in CMO management, chemical manufacturing, or similar roles involving a variety of chemical syntheses in laboratory and manufacturing settings.

• Proven experience in reviewing manufacturing and executed batch records, operating procedures, non-conformances, and change controls.

• Experience in fostering business partner relationships.

• Ability to interpret written chemical synthesis processes and transform them into industrial execution instructions.

• Proficient in utilizing technologies and applications for gathering, analyzing, and archiving extensive data packages for regulatory submissions.

• Familiarity with cGMPs, industry regulations, standards, and laws.

• Exceptional written and visual communication abilities.

• Capability to build strong relationships both internally and externally.

• Self-driven and able to enhance a productive, collaborative team atmosphere.

• Highly organized and attentive to detail.

• Willingness and adaptability to travel as required, including participating in on-site activities at CMOs globally.

• Comfort with frequent computer/device usage, screen work, basic manual coordination, clear communication, and sustained focus.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-sponsored life insurance.

• Accidental Death & Dismemberment (AD&D) benefits.

• Disability insurance benefits.

• Voluntary options to customize coverage.

• Dollar-for-dollar 401(k) matching up to 6% on eligible contributions.

• Long-term stock incentive programs.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.

• Reasonable accommodations provided for individuals with disabilities.