- Conduct development, qualification, and validation of qualitative and quantitative immunoassays for drug PK, anti-drug antibodies (ADA) and biomarkers in biological matrices
- Conduct development, qualification, and validation of cell-based binding and neutralizing assays
- 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
- Involve in generation and characterization of critical reagents in support of bioanalytical methods
- Support CRO transfer, validation and sample analysis of PK/ADA assays to ensure high quality of the methods and timely data delivery
- Prepare and review Standard Operating Procedures (SOP), validation and bioanalytical study protocols and reports
- Stay updated on the bioanalytical techniques and regulatory requirements
- Comply with EHS policies, GXPs regulations and regulatory standards in the bioanalytical group
- Maintain excellent levels of housekeeping, safety and environmental standards within the laboratory
- None
- BS Degree in biological science or related field and a minimum of 3 years of relevant work experience; or,
- MS Degree in biological science or related field and a minimum of 1 year of relevant work experience; or,
- Equivalent combination of education and experience.
- 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 is 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 is a plus
- Prior experience and good understanding of cell-based binding and neutralizing assay development, cell culture techniques and flow cytometry methods are desired
- Good organizational, documentation and technical writing skills required
- 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 Prism, etc.)
- Experience with eLN electronic lab notebook management system
- Detail oriented
- Ability to think critically and creatively
- Strong data analytical skills
- Ability to deliver on multiple high priority tasks
- Excellent interpersonal, organization and communication skills
- Team player with a positive mindset
- 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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Bioanalysis Scientist III - Alameda, United States - Exelixis
Description
SUMMARY/JOB PURPOSE:
The Bioanalysis Scientist III 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 limited to, measurement of drug pharmacokinetics (PK), assessment of immunogenicity, and evaluation of biomarkers. The Bioanalysis Scientist III performs hands-on experiments in the laboratory to support various biotherapeutics projects to meet company objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
SUPERVISORY RESPONSIBILITIES:
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
Experience/The Ideal for Successful Entry into Job:
Knowledge/Skills:
JOB COMPLEXITY:
#LI-CW1
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 $87,250 - $124,250 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.
