Senior Process Engineer, Drug Substance

Praxis

. Work closely with Contract Manufacturing Organizations (CMOs) to support and validate processes for manufacturing small molecule Active Pharmaceutical Ingredients (APIs) .

Posted 10/9/2026full-timeRemote • United StatesSenior💰 $110,000 - $125,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing relationships with Contract Manufacturing Organizations (CMOs) and translating chemical synthesis processes into industrial execution instructions. Proficient in regulatory compliance, data analysis, and maintaining high standards of quality in pharmaceutical manufacturing.

Highest-signal resume keywords

CMO ManagementChemical ManufacturingRegulatory FilingsCGMP KnowledgeData Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Chemical EngineeringProcess ValidationBatch Record ReviewSynthesis Process TranslationData ArchivingRegulatory ComplianceProcess Manual AuthoringRisk IdentificationChange Control ReviewQuality Assurance Collaboration

Soft Skills

Excellent CommunicationRelationship BuildingSelf-MotivatedHighly OrganizedDetail-Oriented

Tools & Technologies

Data Analysis ApplicationsScale-Up Spreadsheets

Industry Keywords

Active Pharmaceutical IngredientsPharmaceutical IndustryFine ChemicalsCGMP StandardsIndustry Guidelines

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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