Bench Scientist

Job Title: Bench Scientist
Job Description: Position Summary
This position within the Bioassay and Impurity Testing Group is responsible for the development, maintenance and testing of bioassays to evaluate the potency of biological candidates in clinical development. The methods may be used for release and stability testing, and product characterization. The successful candidate will have a thorough understanding and knowledge of cell culture and the development of cell based functional assays. Prior experience in assay validation is highly desirable, as well as experience working in cGMP environment. Excellent writing skills, and the ability to document and communicate results to a wide array of scientists and management will be critical. Ability to multitask while working with multiple people in a team-based environment is a requirement.
Position Responsibilities
Method development, qualification, validation, transfer, and sample testing in a cGMP environment is the primary function. Working within a team setting, the qualified candidate will be responsible for developing cell based analytical methods to monitor the intended mechanism of action of drug candidates. Additional work may include developing ELISAs, immunoassays, or other ligand binding assays. This data is required to elucidate structure-function and to confirm suitable quality of clinical supplies. These will be used in a broad portfolio including monoclonal antibodies, antibody-drug conjugates, therapeutic proteins and vaccines.
MINIMUM: B.A. / B.S. or M.S. in biology, biochemistry, cell biology, immunology, or related field
MINIMUM: Cell culture experience. 2-4 years of experience developing cell-based assays and immunoassays for biotherapeutic drug candidates, preferably in a GxP environment. Proven record of delivering results in a fast paced environment and effective communication to project teams. Demonstrated technical writing skills and good interpersonal skills a must.
DESIRABLE: ICH method validation experience. More than 2 years of experience in a GxP (GLP, GMP) environment and implementation of continuous improvement practices. Experience with biotherapeutic development and sample testing.
Comfortable and effective in a team-based, fast-paced environment where multi-tasking required
Comfortable giving presentations in project and group meetings
Effective verbal and written communication skills
Technical Skills
Cell culture experience
Cell-based bioassay or immunoassay development
Biotherapeutic development
Ligand binding assay development (e.g. ELISA, MSD)
ICH method validation
GMP release and stability testing
Skills: Skills Skills
Skills:Category Name Required Experience
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Additional Skills:

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