Bioanalysis Director

SUMMARY:

The Bioanalysis Director will provide management and oversight for CRO-outsourced bioanalysis of biologics (bispecific antibodies and antibody-drug conjugates (ADC). The bioanalysis includes PK, ADA/NAB and biomarker assay development/validation and sample testing in support of non-clinical and clinical trials. The Bioanalysis Director will assist in setting and maintaining GxP processes at the Exelixis internal bioanalytical laboratory.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide scientific expertise and management for the development/validation/sample analysis of anti-drug antibodies (ADA) including neutralizing anti-drug antibodies (Nab) in support of non-clinical and clinical development of ADCs and bispecific antibodies

• Provide scientific expertise and management for the development/validation/sample analysis of pharmacokinetic (PK) or biomarkers in non-clinical and clinical development of ADCs and bispecific antibodies

• Manage and oversee CRO outsourced PK/ADA bioanalysis of small molecules and biologics in single-agent and combination clinical studies

• Work closely with strategic sourcing on setting up and managing contracts with CROs and other vendors

• Provide technical and operational support for critical reagent (such as anti-idiotypic antibodies, recombinant antigens) generation and their life cycle management

• Assist in setting up and maintaining an internal GxP bioanalytical lab and associated procedures, equipment, and systems

• Collaborate with Exelixis QA and QM&B groups to evaluate GLP and GCP compliance of in-house and CRO-outsourced bioanalysis

• Review Standard Operating Procedures (SOP), validation and bioanalytical study protocols and reports and contribute to IND, NDA and BLA filings

• Stay updated on the bioanalytical techniques and GxP regulatory requirements

• Comply with EHS policies

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/SKILLS: 

Education:

• BS or BA Degree in biological science or related field and a minimum of 13 years of relevant work experience; or,

• MS Degree in biological science or related field and a minimum of 11 years of relevant work experience; or,

• PhD degree or equivalent in biological science or a related discipline and a minimum of 8 years of relevant work experience; or,

• Equivalent combination of education and experience.

Experience:

• Track record and strong experience in ADA/Nab bioanalysis in support of clinical non-clinical and trials

• Proficient with immunoassay and cell-based assay development and validation for ADA and NAb

• Experience with ligand-binding (LBA) and hybrid-LCMS methods in support of PK bioanalysis for ADCs

• Experience in regulated bioanalysis of small molecules and biologics (bispecific antibodies and ADC)

• Good understanding and experience in anti-idiotypic antibody generation and critical reagent life cycle management

• Industry experience with biologics at GLP-Tox and clinical-stage programs. Good understanding of regulatory requirements for method development and validation for PK, immunogenicity and PD biomarkers

• Knowledge and experience in GLP/GCP requirements and practices in the bioanalytical lab

• Experience with regulatory interactions is a plus

• Project management is a plus

Knowledge/Skills/Abilities:

• High level of expertise in bioanalytical methods and technology platforms

• Experience with assay development and validation and troubleshooting of immunochemical, bioassays and hybrid-LCMS assays.

• Applied knowledge and expertise with GLP and GCP regulations

• Proficiency with Microsoft office software (Word, Excel, PowerPoint) and graphical computer programs (e.g., GraphPad, etc.).

• Detail-oriented, good organizational, documentation, and technical writing skills.

• Excellent interpersonal, organization and communication skills

JOB COMPLEXITY:

• Applies working knowledge of scientific, technical and quality management principles to solve problems (assays, processes, equipment, etc.).

• Work on diverse scope of problems including scientific, technical, operational and compliance

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