Senior Scientist

Company: Takeda Pharmaceutical
Location: Chelsea
Posted on: May 13, 2022

Job Description:

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Job Description
Senior Scientist
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist in our Kendall Square, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Senior Scientist working on the Clinical Biomarker Innovation & Development team, you will be empowered to drive its pharmacokinetics and immunogenicity strategy design and implementation .

A typical day will include:

POSITION OBJECTIVES:
Contribute in developing a strong and compelling vision for the Bioanalytical Sciences organization, which ensures meeting critical needs of the company, and its development and commercial pipeline.
Provide technical, drug development and regulatory expertise in all aspects of bioanalytical sciences-with emphasize on pharmacokinetics and immunogenicity on different therapeutic modalities including therapeutic antibodies, ADC, recombinant human proteins/enzymes, multidomain fusion proteins, cell & gene therapies.
Develop and leverage cutting-edge technologies that can significantly impact clinical drug development.
Design and implement PK and immunogenicity assessment strategy to support various programs cross different modalities .

POSITION ACCOUNTABILITIES:
SME for immunogenicity assessment, risk mitigation strategies, and up to date on current regulatory guidance and industry recommendation.
Represent BAS and CBID at internal scientific reviews, program team meetings, external forums and consortia.
Drive, develop and oversee execution of bioanalytical strategy and plans within the BAS group and Takeda designated CROs.
Responsible for group's delivery of clinical bioanalytical results and reports, and regulatory requirements for assay development, validation and clinical studies.
Provide bioanalytical scientific expertise to support robust and timely-decision making through all stages of clinical development at program team meetings and during regulatory interactions.
Build relationships & collaborate with scientific leaders, KOLs, academic partners and CROs .
Oversee and provide technical support to external laboratories responsible for testing clinical bioanalytical samples.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
A PhD or MD/PhD in pharmacology, immunology or related discipline with at least 8 year experiences in the industry
A track record of sustained, significant scientific contributions as demonstrated by publications, patents and presentations
Extensive drug development experience from phase I to approval and supporting post-marketing/commercial activities
Strong scientific background and experience with clinical bioanalytical assay development and validation
Subject matter expert in PK and immunogenicity assay strategy design and implements, experiences in cell and gene therapy is plus
Capable of applying the highest scientific and technical standards for the successful design and execution of clinical bioanalytical assays implemented from early to late-stage clinical programs

Takeda U.S. Vaccine Requirement:
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.

In accordance with the CO Equal Pay Act, -Colorado Applicants Are Not Permitted to Apply.

TRAVEL REQUIREMENTS:

Some domestic travel to Takeda sites and bioanalysis vendors may be required.

WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.
*KB-LI

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
Cambridge, MA

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Chelsea , Senior Scientist, Other , Chelsea, Massachusetts