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Scientist/Senior Scientist, Analytical Development - Cell Therapies
Analytical Development, Cell Therapies is looking for a highly motivated Scientist/Senior Scientist to support assay development, characterization and routine testing activities to support Takeda’s cell-based therapy programs. The candidate will play an integral role in driving analytical method development and transfer. He/She will have a cell biology or immunology background and possess in-depth knowledge of multiparameter flow cytometry techniques and their development and validation. Additionally, this position requires attention to detail, organization and knowledge of good laboratory documentation practices. The candidate will be responsible for independently planning and is accountable for assay development, and qualification strategy. Experience with cell-based assays, flow cytometry and other immune-assays are required. Emphasis with be on multiparameter flow cytometry techniques and flow-based analytics. Able to design experimental outlines, method development, validation and transfer of methods to internal and external laboratories. Clearly communicate study results at team or department meetings, to external partners or at conferences.
Influence and supports initiatives related to driving scientific and technical improvements with functions / cross-functions
Develop, improve robustness and qualify phase appropriate analytical methods for clinical stage programs
Collaborate with multiple teams from discovery and development organization to accelerate programs to IND and BLA
Author and review analytical methods, qualification protocols and technical reports
Review, analyze and interpret statistical data and communicates data cross functionally and within CMC project teams
Ensures a productive and development rich environment, provides training/ mentoring for junior staff and leverages expertise in laboratory technology.
Influence of project strategy and communicates complex data/decisions within department and cross functionally as necessary
Identify, builds and maintains relationships with vendors, and quality check study design, and gain access to technologies to deliver pipeline goals.
Work closely with research teams to implement findings and assay development into manufacturing processes.
Analyze experimental data and ensure timely documentation and record keeping in Electronic Notebook.
Stay updated on new, relevant technologies and published literature to drive innovation within the group.
DIMENSIONS AND ASPECTS:
Education, Behavioral Competencies:
PhD degree in cell biology, immunology, pharmaceutical sciences or related scientific discipline with 3+ years relevant experience in biopharmaceutical industry
Masters in cell biology, chemistry immunology or related scientific discipline with 9+years relevant experience in biopharmaceutical industry
BS in biology, chemistry immunology or related scientific discipline with 12+ years industry experience
Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s
Sound knowledge of current Good Manufacturing Practices (cGMP)
Previous experience contributing to regulatory filings
Knowledge and Skills:
Effective project and resource management skills
Excellent oral and written communication skills to present data and strategy across Takeda network
Deep expertise in analytical methods for biologics characterization and commercial release
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
Teamwork - Ability to work well in highly cross functional team environment and across global line functions.
Resource Management -Ability to manage one’s time within individual, departmental, and corporate goals and timelines
Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
Line Function Specific Qualifications:
Broad expertise in wide range of analytical methods including but not limited to cell-based potency assays, flow cytometry, ELISAs multiplex and molecular assays to evaluated biological properties and process impurities.
Deep experience of GMP manufacturing process, assay design and validation, cell therapy or biologics drug development.
Strong understanding of tech transfer, product release & characterization and vendor / CRO is preferred.
Extensive experience in CMC pharmaceutical development.
Excellent organizational and communication skills.
Able to work independently and function within a collaborative/team-oriented environment.
Innovative, critical and creative thinker, unafraid to propose aggressive solutions to complex problems.
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
This job posting excludes CO applicants.
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.