Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Job Description

The Senior Scientist I, Bioanalytics will be responsible for assay development, validation, and sample testing to support non-clinical and clinical studies for a fast growing Exelixis pipeline of novel biotherapeutics. The assays will include, but not be limited to, measurement of drug pharmacokinetic (PK), assessment of immunogenicity and evaluation of biomarkers. The Senior Scientist Iwill lead development of innovative bioanalytical methods and manage Contract Research Organization (CRO) outsourced bioanalysis of biologics and small molecules. She/ he will provide technical expertise and troubleshooting to ensure quality of bioanalysis and timely delivery.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead development, qualification, and validation of qualitative and quantitative immunoassays for drug PK, anti-drug antibodies (ADA) and biomarkers in biological matrices
• Conduct bioanalytical sample analysis for non-GLP and clinical studies
• Implement and utilize multiple technology platforms including MSD, Luminex, Simoa and colorimetric / luminescent plate readers
• Work closely with Translational Medicine and Discovery teams to establish and implement innovative assays to support pharmacodynamic, disease and clinical biomarker assessments
• Serve as subject matter expert for generation and characterization of critical reagents in support of bioanalytical methods
• Oversee CRO transfer, validation and sample analysis of PK/ADA assays to ensure high quality of the methods and timely data delivery.
• Work closely with outsourcing to manage contracts with CROs and other vendors
• Prepare and 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 regulatory requirements
• Comply with EHS policies, GXPs regulations and regulatory standards in the bioanalytical group

SUPERVISORY RESPONSIBILITIES:
• Mentoring junior staff members

EDUCATION/EXPERIENCE/SKILLS:

Education:
• BS Degree in biological science or related field with 13+ years of relevant work experience
• MS Degree in biological science or related field with 11+years of relevant work experience
• PhD degree or equivalent in biological science or a related discipline with 5+ years of relevant work experience

Experience:

• Strong background in immunochemical ligand binding such as MSD and ELISA and general knowledge of antibodies
• Experience with Luminex, Simoa is desired
• Experience working with biological matrices such as whole blood, serum and plasma
• Good understanding of regulatory requirements for method development and validation for PK, immunogenicity and biomarkers
• Experience with method transfers, interactions with CROs desired
• Experience with antibody-drug conjugates (ADC) is a plus
• Good understanding of biochemical methods such as FPLC, HPLC-SEC, CE-SDS for characterization of monoclonal antibodies and recombinant proteins
• Prior experience and good understanding of cell-based assay development, cell culture techniques and flow cytometry methods are desired
• Good organizational, documentation and technical writing skills required

Knowledge/Skills/Abilities:

• High level of expertise in bioanalytical methods and technology platforms
• Experience with development, validation, and troubleshooting of immunochemical and cell-based assays.
• Understanding GLP and GCP regulations as relates to bioanalysis
• Proficiency with Microsoft office software (Word, Excel, Power Point) and graphical computer programs (e.g. GraphPad, etc.).
• Ability to deliver on multiple high priority tasks.
• Detail oriented, good organizational, documentation and technical writing skills.
• Ability to work collaboratively with cross-functional teams.
• 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
• Must be able to function under minimum supervision

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Additional Information

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.