- Particiapte 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.
- Particiapte in the development of and execute assays as needed.
- Participate in the creation and review of necessary SOPs and development reports.
- Participate in the development of presentations of scientific data
location: Cambridge, Massachusetts
job type: Contract
salary: $40.00 - 47.16 per hour
work hours: 9 to 5
- Responsible for development, qualification, documentation, and transfer of assays.
- Compile data 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.
- 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.
- Impelementations and develop drafts of new methods and technologies for project advancement.
- Pariticapte in collaborations with contract testing organizations (CTOs).
- Write and maintain accurate, complete, and timely data in laboratory notebooks.
- PhD in a scientific discipline with a minimum of 4+ years industry experience (may include post doctoral experience), or a MS with a minimum of 4 years industry experience, or a BS with a minimum of 8+ 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.
- 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 Company safety practices and standard operating procedures.
- Exhibit and promote Company Core Competencies.
skills: SOP, Assay Development, Assay Method, Assay Verification
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.