Scientist II, Biomarker Science & Technologies
Posted on: May 29, 2023
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAbout the role:Are you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as a Scientist II in our
Cambridge, 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 Scientist II working in the Biomarker Science and
Technologies team, you will be empowered to independently execute
bioanalytical assay development and/or supervise bioanalytical
support for multiple drug assets, ensuring bioanalytical
deliverable are met.OBJECTIVES:
- The successful applicant will be responsible for the
development and implementation of innovative bioanalytical methods
using sample techniques in conjunction with LC/MS-based detection
in support of clinical drug assets such as small molecules drug
candidates or biomarkers.
- A strong working knowledge of the global BMV guidance and track
record of global Regulatory interactions is a plus.
- The individual will also work closely with internal and
external partners as part of a matrixed assay transfer,
development, and validation team.
- Successful applicant will independently execute bioanalytical
chemistry support for multiple compounds, ensuring that
bioanalytical support is completed in a timely manner, meets
current scientific and quality standards, and adequately supports
global regulatory submissions.
- Scope of responsibility focused on development of analytical
strategy and implementation for LC/MS-based method development,
transfer, and validation activities at qualified vendors. Incumbent
is also responsible for coordination of sample analyses at
bioanalytical vendors, monitoring bioanalytical vendors to ensure
quality, assay results, and bioanalytical reports supporting PK,
immunogenicity, and biomarker endpoints.
- This position requires strong bioanalytical expertise,
knowledge of regulatory environment, experience with sample
extraction procedures and triple quadrupole (Sciex,Thermo) with
high resolution mass spectrometry a plus.
- Responsible for providing strategic input and scientific
expertise to global project teams on all issues relevant to
- Expected to independently manage and resolve any problems or
issues relevant to bioanalytical chemistry while keeping manager
informed of critical issues in a timely manner.How you will
- Responsible for executing, developing, and implementing the
bioanalytical assay strategy for multiple global development
programs, oversight of assay transfer, development and validation
- Develop partnerships in a matrix environment, influencing
project assay strategies.
- Supports Phase 1-4 clinical studies by providing input during
synopsis and protocol preparation, coordinating sample shipment
from clinical sites, and overseeing sample analyses at the
- Responsible for providing scientific and technical oversight to
the bioanalytical vendor during method development, transfer,
validation, or production (including on-site audit of data).
- Responsible forpreliminary and final assay results and working
with the project scientists to ensure that appropriate re-assays
- Provides scientific expertise to relevant scientists for
trouble-shooting bioanalytical issues in clinical studies.
- Responsible for ensuring final assay reports are complete and
accurate and meet regulatory filing requirements.
- Provides input to appropriate sections of clinical study
- Responsible for preparing and/or providing input on regulatory
documents including: Investigational New Drug Applications (IND),
Regulatory Briefing Documents, Investigational Brochures (IB),
Investigational Medicinal Product Dossiers (IMPD), Common Technical
Documents (CTD) as the basis for New Drug Applications (NDA, BLA)
in the U.S. and Market Authorization Applications (MAA) in the EU,
IND annual reports, EMA/CHMP documents, and scientific white
- Represent Takeda at external meetings and conferences as well
as establish the reputation of Takeda with key opinion leaders,
practitioners, partners and agents, and the public at large.
- Collaboratively interact with scientists from other functional
areas in TGRD-US, as well as from other Takeda divisions,
affiliates, and alliance partners.
- Identify and recommend improvements to departmental
- Ph.D. degree preferred and minimum of 2 years of bioanalytical
chemistry or other relevant experience; M.S. degree with minimum of
8 years of bioanalytical chemistry or other relevant experience;
B.S. degree with minimum of 10 years of bioanalytical chemistry or
other relevant experience
- An educational degree is expected in a relevant scientific
area, e.g., Chemistry, Biochemistry, Immunology, etc.
- In depth, expert knowledge of bioanalytical chemistry,
immunoanalytical techniques in addition to triple quad and
high-resolution mass spectrometry expertise.
- Drug development experience from a bioanalytical chemistry
perspective is required.
- Strong knowledge of allied fields critical for drug
development, such as drug metabolism, pharmacology, toxicology, and
pharmaceutical science is expected.
- Thorough understanding of drug development and global
- Excellent oral and written communication skills, including
writing, reviewing, and editing scientific documents.
- Ability to be an effective member of multi-disciplinary project
- Access to transportation to attend various meetings held in
proximity to the Takeda offices.
- Able to fly to various meetings at investigator, vendor or
regulatory agency sites.
- Some international travel may be requiredWhat Takeda can offer
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursementMore about us:At Takeda, we are
transforming patient care through the development of novel
specialty pharmaceuticals and best in class patient support
programs. Takeda is a patient-focused company that will inspire and
empower you to grow through life-changing work.Certified as a
Global Top Employer, Takeda offers stimulating careers, encourages
innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams
are united by an unwavering commitment to deliver Better Health and
a Brighter Future to people around the world.LOCATION:
- Cambridge, MAIn accordance with the CO Equal Pay Act, Colorado
Applicants Are Not Permitted to Apply.EEO StatementTakeda 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda, Boston , Scientist II, Biomarker Science & Technologies, IT / Software / Systems , Boston, Massachusetts
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