Job Description

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Job Description

Job Title: Manufacturing Operations Manager

Location: Lexington, MA (Onsite)

About the role:

As a Manufacturing Operations Manager, you will hire, manage and develop supervisory and operations staff for sustaining 24-7 operations for MABioOps manufacturing operations. You will also collaborate with department heads schedule production activities to support the MABioOps manufacturing schedule. You will report to Manufacturing Department Head.

How you will contribute:

• 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 tasks.
• Represent Manufacturing in main projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.).
• 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 triage, investigation root cause analysis and development of CAPA plans.
• Support continuous improvement projects identified through visual management system in partnership with area management.
• Represent Manufacturing in main projects (e.x. capital projects, tech transfers, kaizen events, shutdown etc.).
• Support schedule and governance meetings.
• Advise and collaborate with multiple teams including: Manufacturing, Site Leadership Team members, Process Development, Manufacturing Sciences and Technology, Facilities and Engineering, Quality Control, Materials Management and Warehousing, Production Technology & Support, Supply Chain and Environment, Health & Safety.

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.
• Experience with focus on project management and execution of moderate to complex tasks.
• Operational knowledge of GMP processes and general biopharmaceutical production environment
• Knowledge of cGMPs and applicable agency regulations (such as FDA, EMA)
• Collaborate with and understand the needs of customers, partners, and support tasks to work and ensure agreement.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional training and development opportunities
• Tuition reimbursement

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• 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.
• 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.

This posting excludes Colorado applicants.

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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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