Manufacturing Process Specialist
4 days ago
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 be responsible for supporting the Vivitrol formulation manufacturing process, ensuring quality and efficiency, and providing technical expertise to development and engineering teams.
Key Responsibilities- Support on-going manufacturing efforts in terms of quality and efficiency
- Provide technical expertise to development and engineering teams
- 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 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
- Ensure resolution of deviations, corrective actions, and audit non-compliance items
- Perform process and equipment evaluation to identify risks and weaknesses
- Develop and implement SOPs and GMP documentation
- Establish familiarity with manufacturing activities involved in sterile production
- Develop and implement effective training of 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
- 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 lift/move 50lbs and team-lift 100lbs
- Ability to operate production equipment
- Ability to self-manage and prioritize workload
- Ability to gown properly for clean room operations
- Ability to read and follow company SOPs and guidelines
- 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, and PowerPoint
- Dependable, well-organized, and efficient
- Detail and results-oriented
- Motivated self-starter with a willingness to learn new tasks and skills
- Works well in a team environment
- Strong oral and written communication skills
- Ability to work cross-functionally to meet company objectives
- Positive attitude and understanding of company objectives
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