Manufacturing Process Specialist

3 days ago

Wilmington, Delaware, United States Alkermes Full time
Job Summary

We are seeking a highly skilled and detail-oriented 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, ensuring quality and efficiency, and providing technical expertise to development and engineering teams.

Key Responsibilities
  1. Support on-going manufacturing efforts in terms of quality and efficiency, providing an interface with development and engineering in technology transfer of new processes and process upgrades.
  2. Conduct real-time monitoring and trending of manufacturing processes and finished product analytical data.
  3. Develop and maintain databases providing trending capability for process parameters.
  4. Develop and maintain Vivitrol production metrics through the use of analytical tools.
  5. Conduct frequent and thorough periodic reviews of database and trends, identifying opportunities for improvement in performance, both in process and manpower effectiveness and efficiency.
  6. Actively identify unfavorable trends and investigate root cause, as well as effective preventive actions.
  7. Provide leadership and manufacturing support in investigations, as assigned.
  8. Assure the resolution of deviations, corrective actions, Change Control action items, and any audit non-compliance items.
  9. Ensure the timely completion of assigned deviations and CAPAs.
  10. Perform process and equipment evaluation (FMEA, etc.) to identify risks and weaknesses in new and current processes.
  11. Write/revises, develop, and implement SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
  12. Establish familiarity with all manufacturing activities involved in the sterile production process to share best practices and streamline operations.
  13. Develop and implement effective training of manufacturing personnel related to technical transfer and process upgrades.
  14. Act as a manufacturing liaison in project planning and coordination.
  15. Represent manufacturing on process design teams.
  16. Champion projects as they move into and through the manufacturing areas.
  17. Author, drive, and assure accurate and timely execution of process Change Controls; partner with other bulk groups, when necessary.
  18. Provide regular updates to manufacturing management on the status and issues involved in projects.
  19. Perform troubleshooting of issues and non-conformance items.
  20. Provide administrative support to manufacturing in authoring and reviewing engineering/validation documentation, as assigned.
  21. Support manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regards to (but not limited to): operability, technical accuracy, compliance, and process robustness.
  22. Support production of pharmaceutical formulations.
  23. Maintain individual training proficiency; train operators on processes.
  24. Document all work as required by cGMPs on a timely basis.
  25. Abide by all safety requirements as defined by the company.
  26. Assist with RCRA and safety inspections, as required.
  27. Other tasks as assigned by management.
Requirements

We are looking for a candidate with a BS degree or equivalent experience in a manufacturing, process development, or engineering setting. The ideal candidate will have 1-2 years of experience in a pharmaceutical setting, with a strong understanding of Good Manufacturing Practices (US and EU). The candidate should be able to work in an office and manufacturing environment, with occasional off-shift and/or weekend support.

The successful candidate will have strong knowledge of pharmaceutical manufacturing processes, computer proficiency with JMP, Microsoft Word, Excel, and PowerPoint, and the ability to work cross-functionally to meet company objectives. The candidate should be a motivated self-starter, willing to learn new tasks and skills, and have strong oral and written communication skills.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for manufacturing and process development, we encourage you to apply for this exciting opportunity.

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