Job Title: Associate Director, Upstream Manufacturing Operations

Location: Lexington, MA

About the role:

You will provide management oversight and administration of the Upstream (Bioreactor/Recovery) Lexington Manufacturing Operations, managing the activities of the staff, monitoring the maintenance of equipment and facilities in production, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. You are responsible for the operational readiness related to capacity expansion activities planned for the Upstream Manufacturing area.

This is an on site position that reports to the Head of Manufacturing Operations.

How you will contribute:

• Establish operational directives and department goals following site objectives, identify and lead continuous improvement efforts. Drive improvement efforts related to cross-training and flexibility of the operational team.
• Oversee the manufacturing area schedule to ensure market and inventory demands are met. Staff positions and strive to optimize structure. Ensure training of departmental personnel in cGMPs and SOPs.
• Provide technical expertise to resolve manufacturing exceptions and maintain audit readiness.
• Provide support for project portfolio management (capital projects and technology transfers) and drive operational readiness initiatives related to capacity expansion. Deliver functional area objectives on time and within budget. Monitor expenses and maintain departmental budget.
• Support interdepartmental collaboration to provide continuity between manufacturing sites, and conduct routine staff meetings to ensure communication and engagement
• Ensure staff development plans are in place and routine development discussions are held.
• Ensure Departmental Safety Training is performed and personnel attend Site Safety Meetings to maintain and promote a safe working environment.
• Participate in facility and process inspections by domestic and international regulatory agencies. Ensure that all SOPs and batch records are maintained to reflect current manufacturing methods and are in conformance with product licenses
• Assure that production equipment and facilities are maintained in proper working condition and in a validated mode by assuring use of Change Control procedures
• Ensure submission and completion of all area quality documentation to meet established timelines. Ensure that all compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline.

What you bring to Takeda:

• Bachelor’s degree in Biology, Chemistry or related field with 6 years relevant experience or Master’s degree in Biology, Chemistry or related field with 4 years relevant experience or High School Diploma/GED 10 – 12 years of relevant experience.
• 3 – 5 years of experience as an area Manager in a bioprocessing manufacturing environment.
• Knowledge of cGMPs, other regulatory requirements and aseptic processing is required.

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.
• 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.

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