Senior Research Associate / Associate Scientist: Bioanalytical
Amunix Pharmaceuticals is seeking an experienced, resourceful, hands-on individual to join our expanding Bioanalytical team in the role of Senior Research Associate/ Associate Scientist. The individual will develop and execute quantitative PK and qualitative ADA immunoassays along with sample testing in support of preclinical and clinical studies.
The successful candidate will possess strong scientific knowledge and technical experience in developing, troubleshooting, transferring, optimizing and validating PK and ADA assays for biotherapeutics in biological matrices. He/she must be able to work independently in method development, validation and sample analysis using accepted industry methods with minimal guidance and supervision. The qualified candidate should be knowledgeable of current FDA and EMA GLP/GCP compliance as it relates to bioanalytical PK and ADA methods.
Essential duties and responsibilities include the following:
- Design, develop and execute PK and ADA assays in accordance with current industry standard for drug candidates in support of preclinical and clinical stage oncology programs.
- Analyze, summarize, interpret and present results in reports and tables, facilitating follow-up optimization experiments
- Author protocols, reports and SOPs in support of preclinical and clinical studies
- Effectively communicate with other departments within the organization as well as CROs.
- Provide project summaries/reports in project team meetings.
- BSc. / M.S. in relevant scientific discipline and at least 5+ years of bioanalytical laboratory experience a must. Pharmaceutical, biotechnology or CRO experience highly desirable.
- Extensive knowledge of different PK and ADA formats (LBA, ELISA, MSD, Gyros, Quanterix Simoa etc.) and industry assay validation requirements a must
- Knowledge of other non-ELISA based formats such as Mass-spec, Capillary electrophoresis a plus
- Knowledge of SOP and GLP compliance, terminology and documentation
- Proven ability to think critically and creatively to identify and solve bioanalytical assay development challenges.
- Excellent written and verbal communication skills, and ability to write technical reports.
- Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors
- Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
Amunix is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to save cancer patients’ lives through the development and commercialization of breakthrough therapies that harness the immune system. We have invented XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro-XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix’s two lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality. Amunix is currently located in Mountain View, CA but is moving to South San Francisco in 2020.
Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.