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Job Description

Job Title: Manager, Fractionation Manufacturing

Location: Lexington, MA

About the role:

You will help ramp up a new plasma fractionation facility to bring us additional capacity for fractionation, purification, and fill and finish of biologic medications. You will manage subordinate supervisors and shift operations within the manufacturing department. You will meet safety, quality, production, and financial goals, set standards, and make employment and staffing decisions. You will report to the Associate Director, Fractionation Manufacturing.

How you will contribute:

• Manage daily manufacturing operations to meet safety, quality, production, and financial targets

• Develop the manufacturing team by ensuring robust training plans, career development opportunities, and active coaching/mentoring  

• Interpret and administer manufacturing policies, procedures, and programs

• Emphasize training and implement control systems on the shift to eliminate product discrepancies

• Lead and support manufacturing event investigations from initiation to closure on time to assure compliance with plan. Be a Manufacturing main contact/Subject Matter Expert for product impact decisions.

• Drive and ensure the right goals are implemented and tracked for your shift and cell responsibility.

• Lead by example and maintain production floor presence and focus. Mentor junior level personnel on projects.

• Coordinate necessary manufacturing resources and rally support groups to resolve production-related issues.

• Rapid approach to address production-related issues by providing sustainable long-term solutions.

• Conduct impartial assessment of shift performance – main priority is overall performance of applicable department.

• Constant calibration with other managers focusing on technical background of issue and consequences considered when making decisions.

• Commit to employee feedback and developmental processes.

• Manage shift/team and investigate and resolve disciplinary issues.

• Support and emphasize the Safety and Quality commitments of department.

• Provide resources to assist the department director to meet the annual operating plan and budgetary commitments.

• Will be responsible for driving operational excellence through operations of the plant through Visual Management processes.

• Lead manufacturing production floor and drive results.

What you bring to Takeda:

• Typically requires a bachelor's degree, preferably in Science, Engineering or other related technical field.

• 6+ years of related experience with 3+ years in a manufacturing, supervisor role.

• Advanced supervisory skills

• Have a background in executing within a manufacturing environment supporting manufacturing/production issues, in a FDA-regulated manufacturing environment.

• Experience with implementation and driving accountability through visual management

• Have knowledge of core principles in various manufacturing disciplines (i.e. cell culture / fractionation / purification / aseptic filling / packaging / cGMP facility design), support systems (WFI / RO / clean steam / compressed gasses / HVAC) and facility design.

• Direct experience with manufacturing operations and biotechnology processes is ideal.

• Can solve routine and challenging manufacturing problems.

• Have experience using MS Office software (Word, Excel (can perform