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Job Description

Job Title: Manufacturing Manager

Location: Lexington, MA

About the role:

Reporting to the Manufacturing Department Head, the value stream manager is responsible for the following:

• Hire, manage supervisory and operations staff for sustaining 24-7 operations for MABioOps manufacturing operations
• In collaboration with department heads schedule production activities to support the MABioOps manufacturing schedule
• Accountable to implement Safety CAPAs and quality systems such as CAPA, Change Controls and own process improvements for the department in collaboration with area management, Engineering, Technical Services and other support responsibilities
• Represent Manufacturing in important projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.). Collaborate with support tasks to achieve projects accurately and within established timelines
• Collaborate with support groups and area management to ensure training program is efficient
• Primary representative for department during audits and inspections. Accountable for implementation of regulatory commitments
• Support deviation assessment, investigation root cause analysis and development of CAPA plans
• Lead continuous improvement projects identified through visual management system in partnership with area management

How you will contribute:

• Represent Manufacturing in important projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.). Collaborate with support departments to finish projects accurately and within established timelines.
• Collaborate with area management, Engineering, Technical Services and other support functions to improve manufacturing process, improve projects and training.
• Coordinate routine and non routine suite activities related to manufacturing schedule.
• Support schedule & governance meetings.
• Provide support for Safety CAPAs and quality systems such as CAPA, Change Controls and own process improvements across shifts.
• Participate in facility and process inspections by domestic and international regulatory agencies.
• Staff positions.
• Ensure staff development plans are in place and routine development discussions are held.
• Establish individual goals in accordance with site goals.

What you bring to Takeda:

• Bachelor's degree in Engineering or Physical Sciences and 6 years industry experience or an equivalent level of education and/or related experience
• Prior management and supervisory experience
• Cross-functional experience with focus on project management and execution of moderate to complex tasks
• Strong comprehension of value-based production improvements

Key Skills, Abilities, and Competencies

• Operational knowledge of GMP processes and general biopharmaceutical production environment
• Knowledge of cGMPs and applicable agency regulations (such as FDA, EMA)
• Must be able to collaborate with and understand the needs of customers, stakeholders, and support functions in order to work and achieve alignment.
• Works on problems with diverse scope where analysis of data requires evaluation of identifiable factors
• Independently and collaboratively works on projects of moderate
• Solicits input from other functions as required to facilitate decisions. Acts as the point person for issues related to process and equipment and technology transfers

Other Job Requirements

Must be physically able to complete facility access and GMP gowning requirements

Will be provided company issued phone and be on-call based on standard escalation process for issues related to manufacturing, compliance and safety.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, 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.

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.

#GMSGQ #ZR1 #LI-MA1

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:

U.S. Base Salary Range:

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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