Job Title: Sr. Scientist, BioAnalytical Development (Bioassay)
Location: San Francisco, California (Remote)
Contract Duration: Contract position
Hourly Compensation: $75 - $90 per hour (based on experience)
Job Description:
Clinovo is seeking a Sr. Scientist, BioAnalytical Development (Bioassay) to oversee the development, validation, and implementation of PK, immunogenicity, and cell-based assays for biologics drug candidates in both pre-clinical and clinical development. This fully remote position involves managing CROs and CMOs for developing, validating, and executing bioanalytical assays. The role also entails interpreting and reporting bioanalytical results to support drug discovery and clinical development activities.
Key Responsibilities:
Bioanalytical & Cell-Based Assays Development:
Oversee and guide the development, validation, and implementation of bioanalytical and cell-based potency assays to support GMP manufacture, product characterization, lot release, and stability testing.
Collaboration with External Vendors:
Work with multiple external contract organizations (CROs, CMOs, and contract laboratories) for method transfer, qualification, and validation of QC methods.
Cross-functional Collaboration:
Collaborate closely with internal departments like analytical method development, process development, manufacturing operations, research, development, and quality assurance to achieve corporate objectives.
Regulatory Compliance:
Represent bioanalytical development in cross-functional meetings, ensuring adherence to regulatory standards (FDA, ISO, cGMP, GLP, GCP).
Reporting:
Present scientific findings and bioanalytical results at team meetings, ensuring clear and timely communication.
Required Skills & Experience:
Bioanalytical Expertise:
In-depth knowledge and hands-on experience in bioassay development (ELISA, cell-based assays), including troubleshooting and process development.
Experience with Regulatory Compliance:
Solid experience with the cGMP environment, and knowledge of FDA, ISO, GLP, GCP, and bioanalytical and immunogenicity guidance (FDA/EMA).
Project Management:
Prior experience managing CROs, CMOs, and related bioanalytical and laboratory operations.
Education:
A Master's degree in biology/biochemistry is required. An advanced degree (PhD) is preferred.
Experience:
A minimum of 5 years of experience in biotechnology/pharmaceutical industry, specifically with bioassay development, execution, and troubleshooting.
Additional Skills:
Knowledge of assay technologies such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, and Electrochemiluminescence (MSD).
Expertise in developing automated sample handling and assay processes.
Familiarity with stability study programs and quality control in the drug development process.
Working Conditions:
Work Location: Remote (with occasional travel for face-to-face meetings as needed).
Compensation: $75 - $90 per hour, based on experience.
How to Apply:
Click the Apply Now button to submit your application for the Sr. Scientist, BioAnalytical Development (Bioassay) position at Clinovo.
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