Sterile Production Expert

2 months ago

Wilmington, Delaware, United States Alkermes Full time
Job Summary

We are seeking a highly skilled and experienced Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will be responsible for supporting the Vivitrol formulation manufacturing process and ensuring the highest quality and efficiency standards are met.

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 and trending of manufacturing processes and finished product analytical data
  • Develop and maintain databases for process parameter trending
  • Develop and maintain production metrics through the use of analytical tools
  • Conduct frequent and thorough periodic reviews of database and trends to identify opportunities for improvement
  • Actively identify unfavorable trends and investigate root cause and effective preventive actions
  • Provide leadership and manufacturing support in investigations, as assigned
  • Assure the resolution of deviations, corrective actions, Change Control action items, and audit non-compliance items
  • Ensure the timely completion of assigned deviations and CAPAs
  • Perform process and equipment evaluation to identify risks and weaknesses in new and current processes
  • Write, revise, develop, and implement SOPs and other GMP documentation in support of new or changed manufacturing processes
  • Establish familiarity with all manufacturing activities involved in the sterile production process to share best practices and streamline operations
  • Develop and implement effective training of manufacturing personnel related to technical transfer and process upgrades
  • Act as a manufacturing liaison in project planning and coordination
  • Represent manufacturing on process design teams
  • Champion projects as they move into and through the manufacturing areas
  • Author, drive, and assure accurate and timely execution of process Change Controls
  • Provide regular updates to manufacturing management on the status and issues involved in projects
  • 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 existing and new revisions to manufacturing documentation
  • Support production of pharmaceutical formulations
  • Maintain individual training proficiency and train operators on processes
  • Document all work as required by cGMPs on a timely basis
  • Abide by all safety requirements as defined by the company
  • Assist with RCRA and safety inspections, as required
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 in an orderly and efficient manner, while consistently meeting established deadlines
  • Experience working successfully across departments to meet company objectives
  • Ability to lift/move 50lbs overhead and team-lift 100lbs
  • Ability to operate all types of production equipment
  • Ability to self-manage and prioritize workload
  • Ability to gown properly for clean room operations
  • Ability to read, understand, and follow company SOPs and guidelines
  • Ability to stand or sit for extended periods of time (up to 2 hours at a time)
  • 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 environment
  • Some travel required (< 10%)
Personal Attributes
  • Dependable, well-organized, efficient
  • Detail and results-oriented
  • Motivated self-starter; willing to learn new tasks and skills
  • Works well in a team environment
  • Strong oral and written communication skills
  • Responds quickly to assignments; readily adapts to changing job duties
  • Manages time well; ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlines
  • Ability to work cross-functionally to meet company objectives
  • Positive attitude; displays understanding of and promotes company objectives

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