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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as Head of Analytical Development for the Cell Therapy. You will play a critical role in revolutionizing the way drugs are developed and manufactured at Takeda.

As the Head of Analytical Development, you will be accountable for all Cell Therapy Analytical Development strategy and activities, spanning technical development, method transfer, digitalization, and regulatory submissions. You will oversee a team of around 20 scientists and will be responsible for establishing an inclusive and high-performing culture.

You will be accountable for ensuring optimal interfaces and matrixed ways-of-working across Research Functions. You will have hands-on background in development and implementation of molecular, physical-chemical, and bioassay analytics, spanning the needs of the Cell Therapy modality. Experience across both pharma and biotech environments is preferred. Furthermore, you will have previous demonstrated experience in assay automation and digitalization.

How you will contribute:

• Provide strategic, technical, and scientific leadership towards the development and implementation of innovative, robust, cost-efficient analytical capabilities across Takeda cell therapy platforms and programs, including both Cell DS/DP as well as Viral Vector endpoints.

• Oversee and establish testing strategies (using manual and automated methods) to support process development, process characterization, and stability studies in support of establishing process understanding and control strategies. This includes establishing data trending and visualization platforms that support interpretation of datasets.

• Work closely with other Development leaders (Process and Product Development; Automation; Data & Digital; Strategy) to optimize the development of our drugs, including definition of optimal Control Strategy, Release Assays, and Characterization/Functional Assays.

• Closely coordinate the alignment of the Analytical Development team with other Research functions and leaders, to define matrixed and collaborative ways-of-working that will maximize efficiency, quality, and speed. Accountable for driving the scientific and strategic interactions with our Drug Discovery Units (DDUs) and Preclinical Translation Sciences (PTS) colleagues.

• Provide technical and strategic guidance in the development of a toolbox of fit-for-purpose functional assays that can progress to implementation as potency assays, with phase-specific implementation, in partnership with MSAT and GMP partners.

• Responsible to establish best operational practices across analytical development with respect to sample and data management, data integrity (documentation in notebooks and reports), training, and quality.

• Responsible to establish and manage critical assay reagents, assay controls, and control charts to ensure optimal assay performance.

• Establishes strong relationships and collaborates closely across multiple functions as well as externally with partners (e.g., CROs).

• Authors and reviews technical and scientific documents including but not limited to study protocols and reports, and test methods.

• Collaborates effectively with other CMC team members, and cross functional teams to support regulatory submissions; Represents the analytical function as needed for regulatory interaction and authors analytical sections in regulatory documents as needed.

• Recruits and mentors' talent and manages analytical function with needed capabilities; Responsible for managing the department resources (budget and headcount).

• Serve as a technical beacon for the team by maintaining expertise, reviewing publications, attending conferences and networking across Takeda Functions to support an analytical development community of practice.

• Foster a culture of inclusivity and innovation, ensuring career development and mentorship across associates.

• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members.

Minimum Requirements/Qualifications:

• PhD in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering, or a related discipline with 7+ years relevant industry experience.

• Excellent communication/presentation skills and scientific/technical writing skills.

• Demonstrated ability to work in matrixed teams and resource-constrained environments.

• Excellent interpersonal skills and demonstrated ability to influences across Functional and Company borders.

• Proven track record as Cell Therapy development leader, with breadth of exposure across the spectrum of CMC functional responsibilities.

• Passionate about mentorship, culture, and nurturing the development of scientific talent, with direct experience leading high-performing teams.

• Good understanding of ICH, FDA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development.

• Demonstrates outstanding diligence and competence in a supervisory role.

• Ability to work successfully in both a team/matrix environment as well as independently is required.

• Demonstrated track record with analytical development supporting early and late-stage development of cell and gene therapies or biologics.

• Derives widespread peer respect through scientific leadership and the display of high ethical standards

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.

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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