Head, Clinical Manufacturing

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Job Description

We are seeking an experienced and motivated individual to lead the implementation and operation of Early-Stage Clinical Manufacturing Operations for GMP drug substance (DS) and drug product (DP) for all small molecule, biologic and conjugate modalities. The ideal candidate will be responsible for overseeing all aspects of clinical manufacturing operations related to DS and DP, including facility design and maintenance, material & equipment selection/qualification/management, analytical manufacturing support, operating personnel management and process execution and optimization.  This person will be responsible for the safety and compliance of these operations, aided by our EHS and Quality functions.  Through managing a highly effective, efficient and compliant operation, the candidate will ensure timely delivery of clinical GMP DS and DP supplies.

OBJECTIVES: 

Provide leadership and overall management of this technical operation supporting global PS manufacturing operations across all sites (Cambridge, MA; Lexington, MA; Shonan - Yokohama, Japan) Partner across all PS functions in addition to Global Clinical Supply Chain, Global Regulatory Affairs, Global Manufacturing Sciences and Global Quality to provide operational support of early clinical manufacturing processes Ensure manufacturing processes are capable, compliant, in control, and continuously improved.  This includes phase-appropriate quality control measures and detailed analytical reporting.  The key support services, deliverables, and capabilities within this function include:

• Facility Maintenance and Readiness for Early Clinical Trial Manufacturing

• Ongoing compliance, including but not limited to: GMP, environmental, safety, logistics and materials management

• Operational support for analytical components of manufacturing, including IPC and release and stability testing

• Daily Process Monitoring and Troubleshooting

• Exception investigation management

• Process Improvement and Change Management Implementation

ACCOUNTABILITIES: 

• Lead the finalization and implementation of a new Early Clinical Manufacturing Strategy

• Lead the design, construction, and validation of the Early-Stage Clinical Manufacturing Operations sites, ensuring that the facilities meet regulatory requirements and are optimized for efficient and flexible operation.

• Manage the selection and qualification of materials & equipment, including process development and optimization for early-stage clinical manufacturing.

• Develop and implement standard operating procedures (SOPs) to ensure that all processes are conducted in a consistent and compliant manner.

• Ensure the implementation of comprehensive quality control measures across all stages of clinical manufacturing, from initial material selection to the final product.

• Manage a team of operations and manufacturing personnel, including training, development, and performance evaluation.

• Ensure that clinical supplies are manufactured, released and delivered on time and within budget, while meeting quality and regulatory requirements.

• Ensure predictive Clinical Supply Chain management to guarantee reliable Clinical Study support.

• Collaborate with cross-functional teams, including process development, quality, regulatory, and supply chain, to ensure seamless integration of the site into the broader organization.

• Provide technical leadership and support to ensure that the site(s) is(are) fully optimized for efficient and flexible operation.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

Education:

Bachelor's or Master's degree in a scientific discipline such as chemistry, bio/chemical engineering, biochemistry, or pharmaceutical science.

Experience and Capabilities:

• Minimum of 7-10 years of experience in the biopharmaceutical industry, with a focus on early-stage clinical manufacturing operations

• Significant experience in running pilot plants with GMP or cGMP operations and manufacturing.

• Robust understanding of Quality Systems supporting cGMP manufacturing.

• Strong knowledge of GMP regulations and experience with FDA and/or EMA inspections.

• Proven experience in leading and managing facility design, equipment selection and qualification, and process development and optimization for early-stage clinical manufacturing.

• Excellent project management skills, with a track record of leading successful projects in a cross-functional team environment.

• Strong communication and interpersonal skills, with the ability to build and maintain positive relationships with internal and external stakeholders.

• Ability to think creatively and critically, with a strong problem-solving mindset.

• Ability to work independently and as part of a team in a fast-paced and dynamic environment.

TRAVEL REQUIREMENTS:

• Requires approximately up to 15 % travel, which may include overnight and international travel to visit facilities in their network, attend meetings, other Takeda sites, external manufactures, and another related travel.

• Flexibility to attend early meeting or late meetings due to time zone differences 

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 position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Empowering Our People to Shine

Learn more at takedajobs.com.

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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.

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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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