Manufacturing Process Optimization Specialist

2 days ago


Wilmington, Delaware, United States Alkermes Full time
About the Role

This position is a key member of the Alkermes manufacturing team, responsible for optimizing and supporting pharmaceutical formulation production.

Job Summary

We are seeking a highly skilled Manufacturing Process Optimization Specialist to join our team at Alkermes. In this role, you will support the formulation manufacturing process, working closely with development and engineering teams to transfer new processes and upgrade existing technologies.

Main Responsibilities:
  • Process Optimization: Conduct real-time monitoring and trending of manufacturing processes and finished product analytical data, identifying opportunities for improvement in performance, efficiency, and manpower effectiveness.
  • Trend Analysis: Develop and maintain databases providing trending capability for process parameters, enabling data-driven decision-making.
  • Metric Tracking: Develop and maintain Vivitrol production metrics using analytical tools, facilitating timely identification of areas for improvement.
  • Investigations and Troubleshooting: Actively identify unfavorable trends, investigate root causes, and implement effective preventive actions.
  • Leadership and Support: Provide leadership and manufacturing support in investigations, as assigned, ensuring the resolution of deviations, corrective actions, and audit non-compliance items.
Requirements:
  • Education: BS Degree or equivalent experience; Preferred: BS Degree in Engineering, Chemistry, or Biology.
  • Experience: 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting; Sr. Manufacturing Process Technologist: 5+ years in manufacturing, process development, or engineering in a pharmaceutical setting.
  • Skills/Abilities: Strong knowledge of pharmaceutical manufacturing processes, working knowledge of Good Manufacturing Practices (US and EU), ability to quickly understand detailed and complex processes, computer proficiency with JMP, Microsoft Word, Excel, PowerPoint, ability to work in office and manufacturing environments, and some travel required.
  • Personal Attributes: Dependable, well-organized, efficient, detail-oriented, motivated self-starter, willing to learn new tasks and skills, works well in a team environment, strong oral and written communication skills, and manages time effectively.
What We Offer:
  • Estimated Salary: $85,000 - $110,000 per annum.
  • Benefits: Comprehensive benefits package, including health insurance, retirement plan, paid time off, and professional development opportunities.
  • Culture: Collaborative, dynamic, and innovative work environment that values employee growth and well-being.


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