Senior Manager, Process Engineer – Drug Product
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Job Description
Process Engineer collaborating with CMOs to optimize drug product manufacturing processes. Ensuring readiness for future commercial production in a clinical-stage biopharmaceutical company.
Responsibilities:
- Understand varied formulation processes and transfer drug product processes for industrialized execution by authoring scale up spreadsheets and process manuals
- Efficiently use 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 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
Benefits:
- 99% of premium paid for medical, dental and vision plans
- Company-paid life insurance
- AD&D
- Disability benefits
- Voluntary plans to personalize coverage
- 401(k) contributions match dollar-for-dollar up to 6%
- Long-term stock incentives
- ESPP
- Discretionary quarterly bonus
- Flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns
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