Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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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
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
A typical day will include:
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
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
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 .
SME for immunogenicity assessment, risk mitigation strategies, and
up to date on current regulatory guidance and industry
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
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.
Some domestic travel to Takeda sites and bioanalysis vendors may be
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
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.
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.
Keywords: Takeda Pharmaceutical, Chelsea , Senior Scientist, Other , Chelsea, Massachusetts
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