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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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $160,000 - $226,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.