Manufacturing Process Specialist

5 days ago

Wilmington, Delaware, United States Alkermes Full time
Job Summary

We are seeking a highly skilled Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will play a critical role in supporting the Vivitrol formulation manufacturing process.

Key Responsibilities
  • Support on-going manufacturing efforts in terms of quality and efficiency
  • Interface with Development and Engineering in technology transfer of new processes and process upgrades
  • Provide support to Corrective and Preventive Action programs
  • Conduct real-time monitoring/trending of manufacturing processes and finished product analytical data
  • Develop and maintain databases for process parameter trending
  • Develop and maintain production metrics through analytical tools
  • Conduct periodic reviews of database and trends to identify opportunities for improvement
  • Investigate root cause of unfavorable trends and implement preventive actions
  • Provide leadership and manufacturing support in investigations
  • Assure resolution of deviations, corrective actions, and audit non-compliance items
  • Ensure timely completion of assigned deviations and CAPAs
  • Perform process and equipment evaluation to identify risks and weaknesses
  • Develop and implement SOPs and GMP documentation for new or changed manufacturing processes
  • Establish familiarity with manufacturing activities involved in sterile production
  • Develop and implement effective training for manufacturing personnel
  • Act as a manufacturing liaison in project planning and coordination
  • Represent manufacturing on process design teams
  • Champion projects as they move into and through manufacturing areas
  • Author and execute process Change Controls
  • Provide regular updates to manufacturing management on project status and issues
  • Perform troubleshooting of issues and non-conformance items
  • Provide administrative support to manufacturing in authoring and reviewing engineering/validation documentation
  • Support manufacturing management in periodic review of manufacturing documentation
  • Support production of pharmaceutical formulations
  • Maintain individual training proficiency and train operators on processes
  • Document work as required by cGMPs
  • Abide by all safety requirements
  • Assist with RCRA and safety inspections
Requirements
  • BS Degree or equivalent experience
  • 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting
  • Preferred experience in working on multiple projects and coordinating efforts
  • Ability to work cross-functionally to meet company objectives
  • Strong knowledge of pharmaceutical manufacturing processes and Good Manufacturing Practices
  • Computer proficiency with JMP, Microsoft Word, Excel, and PowerPoint
  • Ability to work in office and manufacturing environment
  • Some travel required
Personal Attributes
  • Dependable, well-organized, and efficient
  • Detail and results-oriented
  • Motivated self-starter with a willingness to learn new tasks and skills
  • Strong oral and written communication skills
  • Ability to work in a team environment and adapt to changing job duties
  • Positive attitude and understanding of company objectives

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