Associate Director, CMC Program Lead, Cell Therapies
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.
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Job Description
Takeda Development Center Americas, Inc. is seeking an Associate Director, CMC Program Lead, Cell Therapies in Cambridge, MA with the following requirements: Master’s degree in Biotechnology, Biomedical Engineering, Bioengineering or related field plus 5 years of related experience. Prior experience must include: Utilize principles of biotechnology, engineering, and good manufacturing practices to develop, transfer, industrialize, and optimize manufacturing processes for cell and / or gene therapy products, including allogeneic therapies; Apply structured problem-solving and process improvement methodologies (DMAIC, Agile, Six Sigma, Lean, FMEA) to drive productivity and product quality improvement in Chemistry, Manufacturing & Control (CMC) processes; Employ technical project management principles (project planning, RACI, Scenario Analysis, performance indicators, strategy matrix, communication plans, Gantt charts) and analyze and interpret development data utilizing analytics software (JMP, Minitab) to drive strategic decision-making, define product strategy, and support roadmap development for product development; Lead cell and gene therapy process development including design of experiment (DoE), process optimization and control studies, unit operation automation and scale-up, technical writing including protocol development, reports, SOP authoring, batch record development and support regulatory submissions including pre-IND briefing book packages and IND filings; Represent Cell Therapy CMC teams in technical, program, and governance forums and drive program strategy and decision-making. Up to 60 percent remote work allowed.
Full time. $221,900.00 - $255,600.00 /year.
Apply on-line at www.takedajobs.com and search for Req # R0137330.
Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWhere 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.
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Design and carry out experiments
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Manage multiple projects
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Document data
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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.
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
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Global Top Employer 2024 Takeda named Global Top Employer for seventh consecutive year. -
Accelerating Next-Generation Cell Therapies Explore more. -
Working Here Explore more.
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