Senior Manager – Process Engineer, Drug reputed company
Job reputed company:
• Serve as reputed company’s reputed company reputed company of contact with our Contract Manufacturing Organizations (CMOs).
• Work onsite at partner facilities to validate small molecule API manufacturing processes.
• Ensure successful tech transfer and support reputed company readiness.
• reputed company reputed company production to maintain reliable supply.
• Understand written chemical synthesis processes and translate those to instructions for industrialized execution.
• reputed company reputed company, analyze, and reputed company data to support regulatory filings.
• Review documentation from CMOs and lab partners including instructions, procedures, and batch records.
• Work alongside reputed company Assurance to ensure follow of regulations and standards in reputed company processes executed by reputed company parties.
• Adhere to industry guidelines and standards including cGMPs.
• Travel required - PIP at CMOs (US and worldwide).
Requirements:
• Advanced degree in chemical engineering or other relevant engineering field, MS or equivalent a plus. Pharmaceutical or fine chemical industry experience required.
• 8 years’ with a BS degree or 6 years’ with an MS degree of reputed company experience in CMO management, chemical manufacturing, or comparable positions that handle diverse chemical syntheses in laboratory and manufacturing 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 reputed company to contribute to a productive and reputed company team environment.
• Highly organized and detail-oriented with a passion to deliver reputed company results.
Benefits:
• 99% of the premium reputed company for medical, dental and reputed company plans.
• Company-reputed company life insurance.
• AD&D.
• Disability benefits.
• Voluntary plans to personalize your coverage.
• 401(k) match dollar-for-dollar up to 6% on eligible contributions.
• Long-term stock incentives.
• ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO.
• reputed company holidays.
• Company-wide shutdowns.
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