Scientist I, Drug Product Development, Vaccine Operations応募後で応募 求人ID R0021506 掲載日 04/23/2021 Location:Boston, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientist I, Drug Product Development, Vaccine Operations 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 Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- Plan and execute vaccine formulation, process development, and scale-up studies to support technology transfer
- Analyze data from development studies and technology transfer activities; author reports for submission to internal and external parties, including regulatory agencies such as the FDA and EMA.
- Technical review and maintenance of cGMP documentation
- Conduct comprehensive characterization of candidate molecules to determine stability and manufacturability profile by applying various biophysical and biochemical techniques: HPLC (SEC; IEX, RP); SDS-PAGE; UV and fluorescence spectroscopy.
- Design and execute process development studies for manufacturing unit operations including filtration, mixing, freeze/thaw, and lyophilization.
- Prepare protocols, technical reports, summaries, for distribution and/or presentation to project teams, and for inclusion in reports and regulatory agency submissions
- Technical review of new and executed batch records, as well as maintenance of GMP documentation.
- Identify continuous improvement and process improvement opportunities.
- Interface with contract testing and manufacturing organizations (CTOs and CMOs) to ensure continuity of clinical supply.
- Write and maintain accurate, complete, and timely data in laboratory notebooks.
- Participate in scientific conferences and/or author manuscripts for submission to scientific journals.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Ph.D. in chemical engineering, pharmaceutical sciences, or related field, Master of science or Master of Engineering with a minimum of 4 years industry experience, or a BS with a minimum of 6 years industry experience.
- Biologics and/or vaccine formulation and process development experience is a plus.
- Thorough understanding of vaccine and protein structure and stability.
- Excellent verbal and written communication and data-analysis skills, including the ability to write technical reports and CMC sections for regulatory submissions
- Well organized and detail oriented, with ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
- Comply with Takeda safety practices and standard operating procedures.
- Exhibit and promote Takeda Core Competencies.
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.