Manufacturing Supervisor –Fractionation Post Viral

Role Summary

The Fractionation Building 5 Supervisor implements and supervises daily activities in Building 5 to meet manufacturing goals and project deadlines while maintaining compliance with cGMPs, EHS guidelines, and applicable regulations. They drive results to support plant objectives, enforce company rules and Takeda values, and coach and mentor staff. The role requires presenting technical reports, managing multiple priorities, and leading by example to promote a compliant, safe, and high-performing culture.

Responsibilities

• Oversee production related activities in Building 5 to ensure manufacturing goals are met.
• Facilitate and verify appropriate training for all employees on the shift (including cGMPs, job skills, safety).
• Ensure assigned projects and deliverables (i.e. corrective actions, exception reports, meeting action items) are completed per the commitment date.
• Implement systems to maintain compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, FDA, and any other regulations that apply.
• Ensure 100% compliance with established department procedures and regulations in producing high quality therapeutic products.
• Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, using the talent management process.
• Interface with computerized (automated) manufacturing control system.
• Be present at the shift transition with the shift supervisor(s) and ensure shift transition/communication to the next incoming shift.
• Lead the daily Tier 1 meeting of their respective cell(s).
• Spend 80% of their shift in the manufacturing area, as feasible
• Will be responsible for driving operational excellence and flawless execution in the areas of cost reduction, discard reduction, annual productivity improvements, inventory turnover, regulatory excellence including exception reduction and internal/external regulatory commitment management, on time delivery and lead time reduction, improving the overall safety of the work environment, leadership development and the ability to create a vibrant continuous improvement culture based on the principles of QLP, Lean Manufacturing, total employee involvement and DMAIC problem solving.
• Act as fill in department Manager/Associate Director in their absence
• Lead/participate in site level EHS/engineering/quality/continuous improvement initiatives

Qualifications

• Required: B.S. degree preferably in a technical Science or Engineering discipline with 5 years related manufacturing experience.
• Required: 2 years leadership experience.
• Preferred: Experience in all aspects of manufacturing process.

Additional Requirements

• Work in a controlled environment requiring protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Remove makeup, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.