Senior Manager, Process Engineer - Drug Product
United States
Full-time
1 month ago
$145,000 - $167,000 USD
H1B Sponsor Likely
Key skills
Process engineeringDrug product manufacturingCMO managementcGMP knowledgePharmaceutical industry experiencecommunicationSelf-motivatedDetail-orientedpipCommunication
About this role
Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. They are seeking a skilled Process Engineer to optimize drug product manufacturing processes and ensure readiness for commercial production.
Responsibilities:
- Ability to understand varied formulation processes and transfer drug product processes for industrialized execution by authoring scale up spreadsheets and process manuals
- Efficient use of technologies and applications to gather, analyze and archive large data packages that can support regulatory filings
- Review relevant documentation from CMOs and lab partners including instructions, procedures, batch records, non-conformances, in-process controls, bulletin of analysis, developmental reports
- Work alongside Quality Assurance to ensure all proper regulations and standards are followed in all our processes being executed by third parties
- Adhere to industry guidelines, standards and laws including being well-versed in cGMPs
- Travel required - PIP at CMOs (US and worldwide)
Requirements:
- Advanced degree in chemical engineering, pharmaceutical sciences or other relevant engineering field, MS or equivalent a plus
- Pharmaceutical industry experience required, e.g. process operations knowledge of sifting, milling, blending, roller compaction, tableting, coating among others
- 8 years' with a BS degree or 6 years' with an MS degree of applied experience in CMO management, drug product manufacturing, or comparable positions that handle diverse environments, reviewing Manufacturing and Executed Batch records, operating procedures, non-conformances, change controls, and fostering business partner relationships
- Excellent written and visual communication skills with an ability to build relationships internally and externally
- Self-motivated and able to contribute to a productive and collaborative team environment
- Highly organized and detail-oriented with a passion to deliver quality results