What are the responsibilities and job description for the Job Posting Title Lead Scientist, Large Molecule Bioanalysis IN OFFICE AUSTIN, TX position at Worldwide Clinical Trials?
What the Lead Scientist, Large Molecule Bioanalysis does at Worldwide
The lead scientist is responsible for designing, developing, and validating ligand binding assays and overseeing clinical sample analysis for immunogenicity and pharmacokinetic (PK) testing of biologics. This position is for a full-time and onsite opportunity at the Worldwide Bioanalytical lab in Austin, TX.
What you will do
- Design and develop PK, Immunogenicity assays for large molecule therapeutics.
- Implement FDA, EMA and ICH recommendations and guidelines for biological assays.
- Troubleshoots ADA and nAb for mAb, bi-specific Abs, ADC, and fusion proteins
- Review and approve bioanalytical validation and study reports
- Review clinical protocols to and RFPs to determine assay requirements for sponsors.
- Ensure study design, sample collection adequately supports ADA and NAb testing requirements.
What you will bring to the role
- Thorough understanding of GLP, GCLP and FDA recommendations/guidelines for PK and immunogenicity assays for biologics.
- Well versed with the MSD and ELISA platforms for application in LBA.
- Writing research white papers, abstracts, research articles
Your experience
- Ph.D in immunology or related biomedical research fields.
- Minimum of 3 years of post-Ph.D. work experience in research involving immunological assays for antibody and/or protein therapeutics.
- Experience in developing, validating, and implementing ligand-binding assays (LBA) for PK, ADA and NAb assays for and antibody and protein therapeutics.
- Experience writing and/or reviewing bioanalytical assay validation plan and study reports.
- Experience in training and managing laboratory personnel.
- Experience interfacing with biopharma clients and working in a collaborative work environment across cross functional teams.
- Experience in data interpretation of ADA and NAb assay results.
- Experience in flow cytometry assays for cell phenotyping and cell-based assays for nAb testing.
