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Associate Director, Analytical Development, Bioanalytics Late Stage

Lexington, Massachusetts
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  • Job Level: Senior
  • Travel: 5-10%

The Pharmaceutical Sciences (Pharm Sci) organization is an integral part of global R&D at Takeda, translating science into therapeutic products for patients. When you join Pharm Sci, you become part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent while minimizing environmental impact.

We work as a member of Takeda’s Global Program Team (GPT) and take full ownership of Chemistry, Manufacturing & Control (CMC) activities — driving product development from bench to bedside.

The Pharm Sci team focuses on executing and enhancing business processes and partnering with key stakeholders and industry leaders to boldly deliver an increasingly complex portfolio. Always looking through a sustainability lens to protect our planet, we are embracing new ways of working, excelling in our data and digital transformation, building differentiated capabilities (CMC Acceleration), delivering innovative medical devices, and advancing an inclusive, innovative culture.

It is an exciting time to be in Pharm Sci. Join our journey and change the lives of patients!

Job ID R0126318 Date posted 11/13/2024 Location Lexington, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Objective / Purpose:

As an Associate Director in Analytical Development, it is expected that the individual will independently lead efforts in development of appropriate scientific methods and technology, implementation of evolving scientific technology, drive team objectives and manage team performance in line with Pharmaceutical Sciences’ strategy to deliver on program strategy and initiatives. The individual is expected to have acquired expertise in benchmarking analytical development trends within industry and demonstrate an in-depth working knowledge of Pharmaceutical Sciences and other partner organizational (Research, GMSGQ) roles and program strategy.   

Accountabilities:

  • Expected to independently conduct technical analyses and risk assessments to build knowledge of processes, methods, and to inform related strategies across program and potentially across Pharmaceutical Sciences especially for Bioanalytics for late stage Biologics programs

  • Manage staff with accountability for performance and talent development

  • Works with senior management to develop and set vision for departmental activities and management of resources.

  • Ownership of Bioanalytics late stage area, responsible for establishing and managing operational processes within the department and influencing scientific and process improvement in global AD.

  • Strong knowledge of ICH and other regulatory guidelines including Analytical Quality by Design (AQbD)

  • Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics

  • Represents AD and provide guidance to PST teams by leveraging cross program learning, demonstrating ability to understand and communicate impact of technical and project risks on program timelines and other PS functions

  • Reviews and interprets complex data, industry trends and incorporates into strategy to communicate clearly to PS functional leadership and partner functional leadership as appropriate.

  • Driving vendors and sourcing/consultancy strategy both internally and externally.

  • Responsible for developing AD skill set to enable department vision, and management of team performance, engaging with external professional/scientific community, may drive publication strategy

  • Complete all required training appropriate to role and function in a timely manner

Education & Competencies:

  • Bachelors degree with 15+ yrs relevant experience, Masters degree with 13+ yrs relevant experience, Ph.D. with 7+ yrs relevant experience

  • Provides technical/managerial leadership for analytical function, in-depth understanding of PS deliverables and program timelines, driving program strategy, demonstrating leadership in functional and cross functional teams

  • Able to communicate to cross functional senior leadership on technology implementation strategy, able to lead or contribute in cross functional teams and ways of working, provide guidance around project leadership and strategy to team members as well as technical guidance  

Takeda is proud in its commitment of 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.

Discover 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.

For Location:

Lexington, MA

U.S. Base Salary Range:

149,100.00 - 234,300.00

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

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes
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Where you fit in

Our teams are experienced in medicinal chemistry, multi-step synthesis, multimodal genetics, genomics datasets, pharmacokinetics and more. So wherever your expertise and passion lie, your work will have tangible outcomes, advancing an innovative pipeline that serves unmet needs.

We're delving deeper than ever inside the human body and its microbiome, implementing innovative approaches to deliver high-quality products that treat a range of illnesses, including IBD and cancer.

In our diverse, forward-thinking culture, we're constantly embracing new ways of working:

  • Partnering with research teams, GPTs, business development and our commercial partners in GMS/GQ
  • Supporting all stages of pre-clinical and clinical development
  • Providing enabling technologies, including formulation and delivery strategies, analytical expertise and IP
  • Developing processes to manufacture high-quality Clinical Trial Material and other
  • Focusing on broad therapeutic areas on multiple device platforms: Advanced Delivery Devices, Home & Point-Of-Care Diagnostics, Software & Connectivity for eHealth devices and state-of-the-art Medical Devices & Combination Products

On our team in Pharmaceutical Sciences, you’ll notice a big difference in your own life, too. You’ll be supported to develop your career. You'll connect with brilliant minds and be recognized for your accomplishments. Your curiosity, skills and dedication will have a place and a purpose. So even when you’re exploring the smallest of details, your world will be bigger than ever.

  • Perform cell processing operations

  • Support clean room activities

  • Ensure equipment maintenance

  • Support investigations in deviations

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.
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Briana Rawson - Lead, Human Factors Engineer

I love that I get to connect smaller, newer ventures with Takeda’s reputation and resources so that we can develop innovative ways of diagnosing and managing the conditions of patients with unmet needs.
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Rachel Whitaker - Principal Engineer, Diagnostic Devices

The heart of our work

Leading with innovation

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

Lexington, Massachusetts


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