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Job Description

Job Title: External Technical Services Lead

Location: Lexington, MA

About the role:

As an External Technical Services Lead, you will lead, manage and coordinate technical support activities for Takeda Biologics Drug Substance and Drug Product at registration and post-registration stages of the product lifecycle, including but not limited to troubleshooting, process improvement, cost reduction, technical transfer and validation. You will also work closely with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as an important point of technical contact between Takeda and multiple contract manufacturing organizations. You will report to the Head of External Technical Services.

How you will contribute:

• Ensure manufacturing readiness by managing process-related lifecycle management projects, CAPAs, and change controls.

• Provide technical leadership to support quality systems governing GMP manufacturing (e.g., deviations, investigations, CAPA and change control), regulatory submissions, and facility inspections. Also, be technical reviewer / approver for manufacturing related documents such as Change Notifications, APQR and MBR.

• Support product release by managing process-related deviations and resolving major process-related manufacturing issues.

• Ensure process robustness by managing process data, analyzing unfavorable trends, and identifying and prioritizing corrective actions. Align business targets with process performance.

• Maintain a state of compliance by authoring process-related sections of PQR, supporting health authority interactions, and maintaining training.

• With Takeda Leadership Behaviors, builds and maintains relationships with important partners within the External Supply Operations Team (i.e. Quality Assurance, External Supply Operations Lead, etc.) and other internal/external key stakeholders. This includes operating collaboratively and promoting a climate that encourages open dialogue, feedback, and diverse opinions.

• Facilitate main program decisions by identifying guiding principles, potential options, relevant considerations, recommendations, potential outcomes and associated mitigations.

• Enhance knowledge management by curating development, validation and regulatory documents and ensuring that main information is accessible and can be shared with partners.

• Champion data-driven decision-making by managing, analyzing, and interpreting manufacturing process data.

• Summarize main observations/possible effects and communicate to partners.

What you bring to Takeda:

• Requires a degree in technical / scientific education with at least 10 years technical industry experience in development and/or manufacturing.

• Experience in the GMP environment, and regulatory affairs.

• Experience managing technical capabilities in a global capacity

• Experience managing budgets, resource allocation and project portfolio management.

• High level of in-depth technical expertise in techniques used in pharmaceutical sciences, such as cell culture, purification, formulation, and aseptic fill/finish.

• Knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.

• Applied Statistics experience to support process understanding and troubleshooting (e.g. JMP, Minitab, etc.).

• Experience in global product launches and the associated CMC regulatory requirements.

• Provide leadership for important deliverables, identifying potential issues and opportunities. Escalates and collaborates with manager and other operational and program team members to find and implement solutions.

• Independently complete deliverables within existing workflows as identified and requested by peers, team members and management.

• Deploy established policies.

• Work with colleagues in Pharmaceutical Sciences, Supply Operations, Quality Assurance and Regulatory Affairs, while serving as an important point of technical contact between Takeda and multiple contract manufacturing organizations.

• Be the main member of External Biologics Supply Operations Team. Represent External Biologics Supply on CMC team.

• Lead across multiple projects in a timeline-driven work environment, while ensuring quality and accuracy.

• Communicate and present complex scientific information to all business audiences

• Demonstrated strength in cross boundary communication, influencing others, building cross-functional teams.

• Develop proficiency with established procedures and ways of working with external partners.

• Align to industry standards and current best practices.

• Potential domestic and international travel (~20%).

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.

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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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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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