Senior Research Associate - NGS, Stability Studies
Oakland-Fremont-Pleasanton Metro Area, CA
The candidate will be part of the stability team in assay development. The candidate will perform and oversee a wide variety of stability testing protocols to support final product and stability studies for Process Development for RUO / IVD assays and applications for use on cutting edge next-generation sequencing systems. The candidate is responsible for making observations and ensuring all documentation is in compliance with procedures and regulations.
- The successful candidate should have a strong background in molecular biology, with hands-on experience designing, optimizing and validating NGS-based assays. IVD assay development experience is highly desirable.
- The successful candidate will perform stability studies and may manage individual projects by understanding the project and provide scientific/technical direction related to stability of reagents and systems.
- Accurately and consistently records all stability experimental data (experimental methods, materials and results) in electronic laboratory notebooks and design history files.
- Responsible for creating / revising and implementing standard operation procedures (SOPs), laboratory records and other related documentation. Prepares and/or reviews study protocols and final summaries/reports, performs analysis and interpretation of data with conclusions/presentations, and determines future experiments.
- Ensures testing is performed in accordance with SOPs and regulations (cGMP and GLP) for all products and operates and maintains lab equipment as required by SOPs and testing procedures.
- May serve as primary contact for project(s) and ensures timely initiation and completion of all studies
- Responsible for initiating, investigating, resolving, and completing event records.
- Good interdepartmental communication skills and ability to interact effectively across groups within a fast-paced environment are required.
- Liaise closely with Quality department and other cross-functional departmental areas to close the events and corrective actions identified during stability testing and provides timely response and follow-ups.
- Attends project meetings, writes reports, and makes risk assessments on stability results. Presents findings or comprehensive project status reviews at internal/external seminars/meetings.
- Contributes/authors scientific publications/manuscripts and presents at conferences/ seminars.
- B.S. or M.S. in Biological/Life Sciences, Chemistry, Biochemistry or related fields
- 5-7 years relevant industry experience, preferred 5 years and above.
- Direct knowledge and experience with stability studies is highly preferred.
- Sequencing experience is highly preferred.