We are seeking candidates to join us in building capabilities to lead the industry in the advancement of novel products to the market through innovation and execution of analytical testing. Working within a team setting, the qualified candidate will contribute to the development of gene therapies (e.g., adeno-associated virus), vaccines, therapeutic proteins and monoclonal antibodies with emphasis on a range of qPCR assays, immunoassays and cell-based bioassays. The qualified candidate will be responsible for performing analytical methods to monitor the intended mechanism of action of drug candidates and to ensure residual process -related impurities are controlled. This data is required to elucidate structure-function and to confirm suitable quality of clinical supplies in a broad biologics portfolio. The candidate will work across analytical functions and projects and will also provide technical counsel to other organizations and senior leadership.
The Senior Associate Scientist 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 characterization for a range of biological candidates in clinical development and process development. The successful candidate will have a thorough understanding and knowledge of cell culture and the development of qPCR assays, immunoassays and cell-based functional assays. Prior experience working in a cGMP environment is highly desirable, as well as any experience in assay validation. 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. ROLE RESPONSIBILITIES
- Responsible for performing and troubleshooting qPCR assays, immunoassays and cell-based assays for early and late stage products in a GMP environment. The candidate is expected to document and report lab work according to GMP practices
- The candidate must be able to interact effectively with multi-disciplinary project teams.
- The candidate is expected to tabulate data, provide data interpretation to their teams and to their customers.
- The candidate is expected to revise, review, and author test methods and technical reports
- The candidate is expected to perform method development, qualification, validation and transfer in a cGMP environment
- Working within a team setting, the qualified candidate will be responsible for developing immunoassays and cell-based assays to monitor the intended mechanism of action of drug candidates.
- Bachelor's or master's degree in biology, biochemistry, cell biology, immunology or related field with 3-6 years of experience developing and performing qPCR, cell-based assays and immunoassays.
- Proven record of delivering results in a fast-paced environment and effective communication to project teams
- Demonstrated technical writing skills and good interpersonal skills
- Experience in GxP (GLP, GMP) environment and implementation of continuous improvement practices
- ddPCR experience
- Method validation experience
- Experience with biotherapeutic development
- Comfortable and effective in a team-based, fast-paced environment where multi-tasking required
Position requires occasional light lifting and periods of standing, sitting or walking. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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Research and Development