Head of Analytical Development, Cell Therapy

Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited

Boston, MA, USA
Posted on Oct 18, 2024

Head of Analytical Development, Cell Therapy

Boston, Massachusetts
  • Job Level: Senior
  • Travel: Minimal (if any)

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

Job ID R0137065 Date posted 10/17/2024 Location Boston, Massachusetts

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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.

For Location:

Boston, MA

U.S. Base Salary Range:

$169,400.00 - $266,200.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Where you fit in

Our team at Takeda is tackling some of the most challenging problems in drug discovery and development. As the newest member of our Research team, you’ll conduct purposeful, meaningful work on groundbreaking modalities that may lead to breakthrough drugs.

With our deep investment in next-generation technologies, you’ll have the resources and support to do your best work. As a part of our team, you’ll connect with brilliant minds inside and outside of Takeda. We are committed to collaborating with academia and emerging biotech companies to expand our reach and impact in cell therapy, gene therapy and data sciences.

Our team’s wide-ranging expertise includes medicinal chemistry, genomics datasets, immunofluorescence, high content imaging, flow cytometry, transcriptional profiling, multi-step synthesis, multimodal genetics, pharmacokinetics and much more. Whatever area inspires you, your work will support the progression of an innovative, industry-leading discovery pipeline and make an impact that matters to patients and society.

A career in Research at Takeda will give you everything you need to succeed professionally — and make a difference to patients, people and the planet.

  • Design and carry out experiments

  • Manage multiple projects

  • Document data

  • Mentor other scientists

Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.

Christina Alves - Head of Biotherapeutics Process Development

I feel especially lucky to be able to work with colleagues across the industry to meet a unified goal.Takeda is paving the way for how research will be conducted in the future.

Daniel Scheibe - Senior Manager Operations, Systems Engineering, Drug Discovery Sciences

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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About our location

Boston, Massachusetts


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