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Job Description

About the role:

As the Head of Manufacturing Support, you will responsible for leading the Manufacturing Compliance, Training, Project Management, and Operations Support teams. This role oversees the development and execution of support team strategies, ensuring effective assistance to internal manufacturing operations. You will enable consistent and compliant delivery of the plan of record, which includes technology transfers and new product introductions, drives continuous improvement within Manufacturing, and supports the realization of the overall manufacturing strategy. You will report into the Head of Manufacturing.

How you will contribute:

• Develop a comprehensive manufacturing support strategy to ensure safe, compliant and efficient MFG operations
• Deliver a high level of customer service for the MFG Operations team
• Lead team subject matter expertise (SME) for cGMP Manufacturing operations, technical training, investigations, quality systems management, and project support
• Develop MFG Training strategy to ensure flexibility and redundancy within Manufacturing operations
• Caching/training of Manufacturing Support Staff
• Promote internal inspection readiness of the Manufacturing Teams
• Facilitation and continuous improvement of management systems, including development and monitoring of metrics intended to drive business process improvements
• Liaise between manufacturing and cross-functional areas as applicable
• Drive the organization towards a culture of innovation, collaboration, best practice, accountability, and efficiency

Minimum Requirements/Qualifications:

• Bachelor's degree or equivalent experience in Engineering or Science and 15+ years of relevant experience in commercial biotechnology or pharmaceutical production
• Strong knowledge of cGMP and other regulatory requirements related to manufacturing biologics
• Ability to think strategically and realize support vision in line with overall manufacturing mission and vision
• Capable of making technically sound and compliant recommendations regarding cGMP operations
• Organizational effectiveness and employee development focus
• Actively seeks ways to improve current systems and processes related to manufacturing and individual activities
• Proactively and systematically seeks and applies best practices for and gap identification
• Understanding of company business, objectives, and operations and how own activities fit within company strategy
• MS Office, LIMS, SAP, TrackWise, EDMS, compliance, and strong scientific understanding

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$174,500.00 - $274,230.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with s