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Orbis Clinical is seeking a Sr. Research Associate II located in Novato, CA for 3 months.
Job Title: Sr. Research Associate II
Location: Novato, CA
Contract: 3 months
Summary
The Bioanalytical Development group seeks a highly motivated Senior Research Associate II to provide Bioanalytical and Biomarker method development in support of the Translational Research team as well as programs in non-clinical and clinical development. We develop, transfer and/or validate bioanalytical methods for quantifying biotherapeutic proteins, biomarkers, and anti-dug antibodies in both regulated and non-regulated environment. Our data and expertise enable characterization of immunogenicity, pharmacokinetic, and biological activities of company’s biotherapeutics during all phases of drug development.
Responsibilities
- Develop, optimize, qualify, and perform bioanalytical assays to support PK, immunogenicity, and biomarker analysis of biotherapeutic programs
- Design and execute ligand-binding assays, hybrid assays, and cell-based assays for non-clinical research and early clinical development
- Support technology transfer of assays to internal groups and contract research organizations (CROs)
- Contribute to method qualification, validation, and sample analysis in compliance with regulatory expectations
- Analyze, compile, and interpret data from multiple assay platforms and studies
- Present results clearly through reports, presentations, and discussions with internal and external stakeholders
- Assist in author and review of technical documents including sample analysis plans, method development reports, validation protocols/reports, and study reports.
- Effectively prioritize and manage workload across diverse assay types and timelines.
- Independently troubleshoot complex technical issues and develop creative solutions.
- Ensure that bioanalytical activities relating to regulatory commitments are supported with quality data and in the time expected. Contribute to writing regulatory documents as needed.
- Investigate and implement new analytical methods, technologies, and platforms to enhance assay performance and capabilities
Requirements
- SRA II:Â MS in Chemistry, Biochemistry, Biology, Immunology, or equivalent with 4-6 years of related experience; or a BS with 6-8 years of related experience
- Experience developing and qualifying ADA, PK, NAb and biomarker assays
- Experience in a broad range of protein techniques including Western, ELISA, multiplexing platforms such as MSD/Luminex, protein expression, PCR, antibody development/characterization
- Demonstrate independence at the bench and ability to work collaboratively on projects
- Experience with data management systems, familiarity with data and statistical analysis software
- Position requires excellent organizational skills and time management to meet deadlines in a fast-paced organization. Ability to multitask and work on diverse projects is an advantage
- Familiarity with regulatory and industry guidance documents including requirements for GLP bioanalytical assays
Compensation Details:
- Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $51.72 per hour, can vary depending on employment status.
- Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).Â
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EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.
