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Bioanalytical Manager
148891
Posted:
21/08/2024th
21/08/2024
- 145000 USD - 170000 USD
- San Francisco , United States
- Permanent
Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer. Reporting to the Associate Director, Clinical Science, the right candidate has a strong background in assay development and validation and a current understanding of industry guidance for regulated bioanalysis. Hands-on experience with PK, ADA, neutralizing antibody, and flow cytometry assays are highly desired; hands-on support working in the lab will be needed in this position. Experience in managing the outsourcing of bioanalytical assays, such as vendor selection and management, technical transfer processes, and lifecycle management of clinical assays is required.
The ideal candidate has a strong lab background and hands-on assay development experience. This individual will have a mix of lab-based responsibilities and vendor management responsibilities. For the right individual, there may be internal growth opportunities within bioanalytical leadership.
RESPONSIBILITIES:
The ideal candidate has a strong lab background and hands-on assay development experience. This individual will have a mix of lab-based responsibilities and vendor management responsibilities. For the right individual, there may be internal growth opportunities within bioanalytical leadership.
RESPONSIBILITIES:
- Oversee internal and external assay development across multiple programs through all stages of drug development
- Review validation protocols, test procedures, raw data, and technical reports to ensure scientific integrity and compliance with GLP, GCLP, and current industry guidance
- Primary interface and manager of external vendors/CROs supporting preclinical and clinical bioanalytical assay development and management
- Manage CROs to develop, validate, and maintain bioanalytical methods
- Oversee transfer, validation, and lifecycle management of assays
- Provide technical support and expertise for troubleshooting
- Responsible for internal assay development and optimization
- Bioanalytical data review, analysis, interpretation, delivery and report writing in support of regulatory filings within program timelines
- Oversight of biosample collection and related documents (i.e., lab manuals, sample tracking, etc.)
- Work closely with cross-functional teams: Research and Development for development of stage-appropriate assays; Clinical Operations for biosample logistics; Clinical Development for clinical data management and presentation
- Complete lab-based activities as needed
- Mentor junior research staff
- Be onsite in Electra’s South San Francisco office 4-5 days per week for lab based and meeting based work
- Familiar with a wide range of bioanalytical platforms (MSD and plate-based analysis, cell-based assays)
- Cell based functional assay experience across different programs is strongly preferred
- Strong technical background in assay development with a keen eye to detail and an ability to creatively tackle technically challenging assays.
- Technical document writing and review in creation of reports, both in the lab and with external lab vendors, SOPs, and regulated documents
- Strong background in project management, including balancing competing timelines across multiple vendors and programs
- Experience in early-phase clinical studies and requirements for labs for study start-up and adapting clinical protocols to bioanalytical lab support
- CRO and/or specialty lab vendor management experience
- Knowledge and understanding of interfacing between Central Labs, Specialty Labs and Bioanalytical Labs
- Ability to work in a fast-paced environment requiring flexibility and clear communication skills
- B.S. with 7+ years of relevant experience or M.S. with 5+ years of relevant experience required
- Experience in project leadership and a track-record of successful development and transfer of assays to GLP laboratories for validation is required
- Experience developing, transferring and managing bioanalytical assays for large molecules is required
- Central lab oversight experience is preferred
- A mix of direct CRO and sponsor working experience is preferred
- Experience working independently with external vendors/CROs, with strong interpersonal capabilities
- Candidates with extensive experience developing, managing, and deploying bioanalytical assays at a vendor/CRO may also apply
Leila Johnston
Division Director