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Job Description

About 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 bioanalytical chemistry.

• 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 contribute:

ACCOUNTABILITIES

• Responsible for executing, developing, and implementing the bioanalytical assay strategy for multiple global development programs, oversight of assay transfer, development and validation deliverables.

• 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 bioanalytical vendor.

• 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 for preliminary and final assay results and working with the project scientists to ensure that appropriate re-assays are conducted

• 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 reports (CSR).

• 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 papers.

• 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 processes.

Minimum Requirements/Qualifications:

• 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 regulatory requirements.

• Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents.

• Ability to be an effective member of multi-disciplinary project teams.

TRAVEL REQUIREMENTS:

• 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 required

What Takeda can offer you:

• 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 health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More 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, MA

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

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time