Scientist II at Biotech/Pharma Cambridge Ma
Contract: one year
- Participate in design, manage and execute testing and studies pertaining to vaccine manufacturing, 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.
- Participate in the development of and execute assays as needed. These include, but are not limited to immunoassays such as ELISA, AlphaLISA, Neutralization Assays, OCTET, MSD and Luminex.
- Participate in the creation and review of necessary SOPs and development reports.
- Participate in the development of presentations of scientific data
??? Responsible for development, qualification, documentation, and transfer of assays.
??? Compile data, document results in electronic notebooks, and author reports summarizing experimental results for both real-time and accelerated studies.
??? Draft method development reports, SOPs, and transfer protocols.
??? Coordinate efforts between different internal and external teams such as Process Development, Bio-analytical, Formulation and Preclinical.
Working hours: 8:30 AM - 5:30 PM
- 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 perform maintenance of lab instrumentation.
- Implementations and develop drafts of new methods and technologies for project advancement.
- Participate in collaborations with contract testing organizations (CTOs).
- Write and maintain accurate, complete, and timely data in laboratory notebooks.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
??? MS in a scientific discipline with a minimum of 2+ years industry experience, or a BS with a minimum of 4+ years industry experience.
??? Knowledge and skills in microbiology and immunology.
??? Training and experience in Design of Experiments and other statistical methodologies.
??? Current knowledge in vaccine literature and basic science related to vaccine development.
??? Strong math skills required. 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.
??? Excellent oral and written communication skills
??? Well organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
??? Good time and project management skills, ability to oversee several projects simultaneously.
??? Comply with Takeda safety practices and standard operating procedures.
??? Exhibit and promote Takeda Core Competencies.
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