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Scientist II - Operations Formulation Development
Scientist II - Operations Formulation Development
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 - Operations Formulation Development , 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
Independently design, manage and execute testing and studies pertaining to vaccine formulation and/or bioanalytics for vaccine products at all stages of development. Coordinate information exchange between both in-house and 3rd party vendors for testing. Develop and execute assays as needed. Manage the creation and review of necessary SOPs and development reports. Present scientific data and represent the team on crossfunctional teams.
Propose strategy and manage development, qualification, documentation, and transfer of assays. Compile data and author reports summarizing experimental results for both real-time and accelerated studies. Author method development reports, SOPs, and transfer protocols. Coordinate efforts between different internal and external teams such as Process Development, Bio-analytical, Formulation and Preclinical. Assume all aspects of testing including sample cataloging, submission, analysis and collection of results. Perform statistical analyses on compiled data as needed and author reports for distribution and/or presentation to project teams. Operate and oversee maintenance of lab instrumentation. Ability to investigate and develop new methods and technologies for project advancement. Coordinate collaborations and contracts with contract testing organizations (CTOs). Write and maintain accurate, complete, and timely data in laboratory notebooks.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- PhD in a scientific discipline with a minimum of 6 years industry experience (may include post doctoral experience), or a MS with a minimum of 8 years industry experience, or a BS with a minimum of 10 years industry experience.
- Knowledge and skills in chemistry and biochemistry (e.g. medicinal chemistry, bioanalytical chemistry, protein chemistry, protein expression).
- Training and experience in Design of Experiments and other statistical methodologies.
- Current knowledge in vaccine literature and basic science related to vaccine development.
- Working knowledge of statistical models for DOE, and familiarity with JMP is highly desirable.
- Remain well versed in regulatory requirements to assure appropriate design and execution of vaccine manufacture and toxicology studies via services of CMO and CROs
- Ability to oversee several projects simultaneously.
- Lifting and moving supplies and equipment (up to 50 pounds).
- Willingness to travel to various meetings or CMO/CRO sites, including overnight trips. International travel may be required.
- Requires less than 5 % travel.
- Effective November 1, 2021, 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. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. 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. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
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.
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.