Principal Scientist, Process Analytical Technologies, Analytical Development, Pharmaceutical Sciences
Takeda Pharmaceutical Company Limited
Principal Scientist, Process Analytical Technologies, Analytical Development, Pharmaceutical Sciences
Fujisawa, Kanagawa- Job Type: Full Time
- 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!
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Job Description
”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
As a Principal Scientist in Analytical Development – Process Analytical Technologies (PAT) group, it is expected that the individual will independently contribute and lead efforts in process analytical technologies in global AD, partner with synthetic molecules and biologics process/product development teams and data scientists and drive cross functional interactions across Pharmaceutical Sciences to deliver on program strategy. The individual is expected to have expertise in multiple areas of process analytical technologies including design, development and implementation and demonstrates working knowledge of other Pharmaceutical Science roles and deliverables.
How you will contribute:
Independently design and execute diverse range of process analytical technologies to develop, optimize, monitor, model, and control pharmaceutical processes, with emphasis on continuous processing of drug substance and drug products.
Expertise with inline spectroscopic methods (UV, IR, Raman) and chemometrics is required.
Familiarity of regulatory requirements (ICH Q2/Q14) for analytical method qualification and validation are desired.
Analytical control strategy/comparability knowledge of existing offline and online/inline methods to facilitate bridging away from the current standard.
Expected to independently propose and implement resolutions to complex technical challenges.
Responsible for significant or sole technical leadership within own program(s), provide technical guidance related to expertise across programs, delivering to organizational DDT (Digital Data and Technology) strategies.
Serves as a technical resource within function, mentoring and training junior employees across multiple technologies.
Reviews and interprets complex data, communicating clearly to functional leadership and relevant line functions.
Leads technology transfer internally and externally, building key vendor relationships.
Able to develop project strategy within AD and cross functionally and guide junior staff.
Prepares documentation for regulatory filings, authors technical reports, may author publications.
Able to work on multiple programs and represent AD within PS/project teams.
Complete all required training appropriate to role and function in a timely manner.
Minimum Requirements/Qualifications:
Bachelors degree with 10+ yrs relevant experience, Masters degree with 8+ yrs relevant experience, Ph.D. with 4 yr relevant experience
Competent in multiple analytical techniques with advanced knowledge in specific analytical and real-time monitoring techniques relevant to analytical function, understands wider PS deliverables and project timelines.
Able to communicate complex data clearly, able to work cross functionally, good scientific writing skills, able to work independently with minimal supervision,
Good command of English language is required
Takeda Compensation and Benefits Summary:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
It is possible the job scope may change at the company’s discretion.
It is possible the department and workplace may change at the company’s discretion.
Locations
Fujisawa, JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWhere 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.
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Perform cell processing operations
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Support clean room activities
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Ensure equipment maintenance
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Support investigations in deviations
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.
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.
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Integrity
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Fairness
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Honesty
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Perseverance
Working at Takeda
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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.
Related Content
- Global Top Employer 2024 Takeda named Global Top Employer for seventh consecutive year.
- Our products The work we do transforms lives.
- Takeda’s Global CSR Program Explore more.
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