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Company: Cepheid Location: Sunnyvale, CA Employment Type: Full Time Date Posted: 04/30/2021 Expire Date: 05/30/2021 Job Categories:
Biotechnology and Pharmaceutical, Computers, Software, Information Technology, Manufacturing and Production, Science, Quality Control, Research & Development
This position is in the Biotechnology group andis primarily a bench level job focusing on real time PCR and RT-PCR assay and product development in an FDA-QSR and ISO9001 compliant organization. The ideal candidate will have experience in general molecular biology and microbiology methods with focus on PCR and RT PCR based in vitro diagnostics, assay design, working with BSL2 organisms and biological specimens. It is highly desirable that the candidate has a proven track-record of launching in vitro diagnostic products and has experience with the key R&D activities (assay design to product validation) involved in the process. In addition to technical qualifications, the ideal candidate will be highly goal-oriented and should be able to respond to shifting demands and priorities as a member of a high performing team and possess excellent oral and written communication skills. The ability to harmonize daily activities to work in a cross-functional team and with outside collaborators is a key requirement. Familiarity with regulatory and QC/QA requirements for successful product launch will be a plus.
ESSENTIAL JOB RESPONSIBILITIES:
Perform real time PCR and RT-PCR assays on the GeneXpert platform, based on design input requirements and optimize sample preparation.
Perform primer/probe designs and modify assay designs to optimize for best performance.
Prepare assay reagents, work with BSL2 organisms and perform real time PCR and melt assay standardization experiments and write detailed study plans and reports.
Rigorously validate the performance characteristics of feasibility, development and production phase cartridge lots.
Regularly analyze large datasets, maintain detailed experimental records and present in regular technical meetings to take decisions on the next steps to help the project move forward.
Ability to work in a highly productive team environment as an effective team player, understanding priorities and work to provide support to the team to realize long and short-term goals.
Ability to quickly adjust priorities and work efficiently for on time delivery of project commitments based on shifting project demands and deadlines.
Help develop and write verification and validation SOPs and technical reports.
Apply analytical problem solving skills to reagent and system integration issues to identify critical performance factors.
Provide input to the project schedule and communicate and collaborate with cross-functional teams as required.
Work with biological fluids like sputum which involves screening clinical samples, performing analytical experiments with contrived samples and maintaining sample repository.
Order reagents, oligonucleotides, supplies as necessary and arrange for shipments to collaborators periodically.
Education or Experience (in years):
BS with 2+ years of experience or MS with0-2 years of experience at a molecular diagnostics or company or related biotechnology industry.
Knowledge and skills:
Real time PCR or RT-PCR and IVD product development experience. Experience of working in teams for successful product launch will be a plus
Experience with primer/probe design and knowledge of primer probe design and sequence alignment software
Experience with design of experiments methods
Ability to independently perform large experiments after initial training and supervision
Ability to clearly analyze experimental results and contribute to team decisions for the next steps to ensure successful outcomes
Experience working with microorganisms involved in infectious diseases. Experience with Mycobacterium will be a plus.
Familiarity with antibiotic/drug resistance in bacteria would be desirable.
Must possess skills/knowledge in handling clinical specimens and be able to work in a BSL-2 environment.
Ability to work in a clean room environment.
Excellent documentation and communications skills.
Proficiency with standard Microsoft computer programs.
Knowledge of Minitab, JMP, Agile tools, DNASTAR will be a plus.
Ability to work in a research laboratory environment which includes periods of bench-work and working in a bio-safety cabinet. Ability to work wearing surgical and N-95 masks.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.