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SalarySUMMARY/JOB PURPOSE:
The Senior Bioanalysis Scientist I is 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 include, but not be limited to, measurement of drug pharmacokinetic (PK), assessment of immunogenicity and evaluation of biomarkers. Leads development of innovative bioanalytical methods and manage Contract Research Organization (CRO) outsourced bioanalysis of biologics and small molecules. Provides technical expertise and troubleshooting to ensure quality of bioanalysis and timely delivery.
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
- Mentor junior staff members
Supervisory Responsibilities:
- None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- Bachelor’s Degree in biological science or related field and a minimum of 7 years of relevant work experience; or,
- Master’s Degree in biological science or related field and a minimum of 5 years of relevant work experience; or,
- PhD degree or equivalent in biological science or a related discipline and 0 or more years of relevant work experience; or,
- Equivalent combination of education and experience
Experience/The Ideal for Successful Entry into Job:
- 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:
- 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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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 $113,000 - $160,000 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.
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.
