Job Title: Sr. Scientist, BioAnalytical Development (Bioassay)
Location: San Francisco (Fully Remote)
Contract Type: Contract
Compensation: $75 - $90 per hour (dependent on experience)
The Sr. Scientist, BioAnalytical Development (Bioassay) is responsible for overseeing the development, validation, and implementation of pharmacokinetic (PK), immunogenicity, and cell-based assays to support biologic drug candidates in pre-clinical and clinical development. The role requires managing contract research organizations (CROs) and contract manufacturing organizations (CMOs) to develop, validate, and execute bioanalytical and cell-based potency assays. The scientist will be responsible for interpreting and reporting bioanalytical results to support drug discovery and clinical development.
This position collaborates closely with internal departments such as analytical method development/characterization, process development, manufacturing operations, research, development, and quality assurance. The successful candidate will represent the bioanalytical department in cross-functional meetings and provide scientific findings. They will also work with external organizations, including CMOs and contract laboratories, on method transfer, qualification/validation, and implementation of quality control (QC) methods.
Assay Development & Validation:
Oversee the development, validation, and implementation of PK, immunogenicity, and cell-based assays to measure potency, ensuring compliance with GMP, GLP, and regulatory guidelines.
Bioanalytical Testing:
Execute bioanalytical testing, including PK, immunogenicity, and potency assays, for lot release, stability testing, and product characterization.
Collaboration:
Work closely with internal departments including process development, manufacturing, research, and quality assurance to meet corporate goals and regulatory requirements.
CRO & CMO Management:
Manage CROs and CMOs to develop and execute bioanalytical assays, ensuring timely and accurate results.
Reporting & Documentation:
Interpret and report bioanalytical results to support clinical development and drug discovery activities. Present findings at team meetings.
Method Transfer & Qualification:
Coordinate method transfer, qualification/validation, and implementation of QC methods in collaboration with contract laboratories and CMOs.
Education:
Experience:
Technical Skills:
Regulatory Knowledge:
Additional Skills:
Interested candidates are invited to submit their updated resume, including relevant work experience, qualifications, and skills.
Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind
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