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Manufacturing Technical Lead

Summary:
The Technical Lead is the shift's technical expert in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).
Responsibilities:
1. Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. ? striving for right first time through adherence of GMP activities.
2. Change control identifiers ? works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation
3. Investigation identifiers ? initiate investigation following alignment with QA floor
4. Communicate and resolve operational variances.
5. Serve as the "acting" Shift Supervisor/Manager in absence of Shift Supervisor/Manager ? Coordinate, direct and oversee work execution and manage personnel related issues.
6. Executes real time process monitoring ? including equipment and key process parameters review and work with Shift Supervisor/Manager to drive required decisions
7. Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team.
8. Participate in performance review discussion
9. Leads complex investigations on floor ? drives technical issues in working with cross functional team members
10. Support real time process reports review and resolve open issues. Trend issues and strives to right first time.
11. Technical trainer for the shift ? provides consistent training to the staff
12. Execute and drive continuous improvements
13. Support Tech transfer team through active participation in ensuring that new process can fit and executes in sustainable manner
14. Being resource to support routine investigations and CAPAs? author, review, approval, in case of excess investigation beyond planned capacity.
15. Assigned area owner ? drive facility upkeeps
16. Adheres to Good Manufacturing Practices and standard operating procedures.
17. Weighs and checks raw materials. Assembles, cleans and sterilizes process equipment, monitors processes.
18. Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
19. Operates and trains others all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.)
20. Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).
21. Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.
22. Assists with the coordination and implementation of special projects such as validation or complex investigations.
23. May provide scheduling and work assignment guidance to peers. Modifies group work plan, schedule or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, regularly provides training and operational guidance to other staff. Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action
Qualifications:
B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
A minimum of 5+ year's process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential.
Demonstrated experience in solving complex technical issues in biologics manufacturing.
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
Previous work experience where attention to detail and personal accountability were critical to success
Demonstrates good interpersonal skills, is attentive and approachable.
Maintains a professional and productive relationship with area management and co-workers.
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.

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