9 Science jobs

A biomedical manufacturing company is seeking a reagent manufacturing chemist to support their swing shift schedule. The company needs a highly motivated experienced individual with reagent production experience. You will be responsible for manufacturing and testing all reagents. You will need to follow established documentation outlining the process, formulation and test requirements to manufacturePCR-based reagents in compliance with standards for GMP's. Work as a Reagent chemist and be responsible for manufacturing the diagnostic reagents. Perform the formulation of buffers and wet reagents. Perform in process, release and LSP testing. This job involves hard work, flexibility and the ability to work in a fast-paced manufacturing environment. This Job requires knowledge of GMP’s and working in compliance with FDA and ISO standards. Responsibilities: Formulate lyophilization buffers and wet reagents Perform dropping the lyophilization reagent beads Experience handling liquid nitrogen Perform in-process, release & LSP testing of reagent beads Involved in the validation of manufacturing process and new products Involved with the problem solving and hand-on laboratory investigation Strong team player – flexible and wiling to assist the other team members Knowledge of reagent bead dropping & lyophilization process Must be able to Train new personnel on the manufacturing process Must be able to clearly and effectively communicate with peers, ME, PT, Supervisors, Managers and Leads to report any issues or provide feedback on the process improvements Assist Supervisor to update build schedule Submit the work order completions

A biomedical manufacturing company located in Sunnyvale, CA is seeking a Failure Investigation Associate Scientist to join their team.  Execute and document analytical and clinical studies Analyze data and prepare graphs and tables to be incorporated into reports. Adhere to standard operating procedures and regulatory requirements Participate in brainstorming, risk management and other reliability activities Support evaluation of potential mitigations and corrective actions Contribute to final report for each project

A biotech manufacturing company in Sunnyvale, CA is looking for a Research Associate to join their biotechnology group. This position is 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 methods. In addition to technical qualifications, the ideal candidate will be highly goal-oriented and be able to respond to shifting demands and priorities and possess excellent oral and written communication skills. The ability to work in a cross-functional team-based environment is crucial. Optimize sample preparation, real time PCR and RT-PCR assays for the GeneXpert platform based on design input requirements. Help develop strategies for development of complex in vitro diagnostic tests. Maintain detailed experimental records. Apply analytical problem solving skills to reagent and system integration issues to identify critical performance factors. Present data at technical meetings. Provide input to the project schedule as required.

A biomedical manufacturing company located in Sunnyvale, CA is seeking a Scientist I to join their Infectious Disease research group. This position is in the Biotechnology R&D group and is 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 candidate will plan and execute laboratory research, demonstrate appropriate technical proficiency, scientific creativity and collaboration with cross-functional departments.  In addition to technical qualifications, the ideal candidate will be highly goal-oriented, organized and be able to thrive in an atmosphere of shifting demands and priorities.  The candidate should possess excellent oral and written communication skills. ESSENTIAL JOB RESPONSIBILITIES: Research and develop molecular diagnostic tests for human viruses or other infectious agents on the company platform. Perform analytical studies required for design verification of complex assays prior to validation phase. Optimize sample preparation, real-time PCR and RT-PCR assays based on design of experiments and design input requirements. Handle blood-base clinical samples and perform microbiology work of BSL-2 organisms, including various bacterial and viral strains. Help develop and write verification and validation SOPs and technical reports. Maintain detailed experimental records. Apply analytical problem-solving skills to reagent and system integration issues to identify critical performance factors. Present data & participate in scientific discussions at the weekly Technical Meeting. May contribute to scientific literature and conferences. Allocate time and resources efficiently, effectively prioritize, and continually seek ways to meet individual, team and corporate goals.

A biomedical manufacturing company is seeking a Reagent Chemist to be responsible for manufacturing the diagnostic reagents.  Perform the formulation of buffers and wet reagents. Perform in-process, release and LSP testing. This job involves high demand, flexibility and ability to work in a fast-paced Manufacturing environment. This job requires knowledge of cGMPs and working in compliance with FDA and ISO standards. Responsibilities: Formulate lyophilization buffers and wet reagents Perform dropping the lyophilizing reagent beads Experience handling liquid nitrogen Perform in-process, release & LSP testing of reagent beads Involved in the validation of manufacturing process and new products Involved with the problem solving and hand-on laboratory investigation Strong team player – flexible and willing to assist the other team member Knowledge of reagent bead dropping & lyophilization process Must be able to train the new personnel on the manufacturing process Must be able to clearly and effectively communicate with peers, ME, PT, Supervisors, managers and leads to report any issues or provide feedbacks on the process improvements Assist supervisor to update the build schedule Submit the Work Order completions

A biomedical manufacturing company located in Sunnyvale, CA is seeking a Research Associate to join their Infectious Disease department. This position is in the Biotechnology R&D group and is primarily a bench level entry position focusing on real time PCR and RT-PCR assay and product development in an FDA-QSR and ISO9001 compliant organization. The candidate will have experience in general molecular genetic methods (Non-protein small molecule biology) while demonstrating excellent laboratory techniques, scientific creativity, and ability to adapt in a fast moving, cross-functional, and collaborative environment. In addition to technical qualifications, the ideal candidate will be highly goal-oriented, organized and be able to respond to shifting demands and priorities. The candidate should possess excellent oral and written communication skills. ESSENTIAL JOB RESPONSIBILITIES: • Research and develop molecular diagnostic tests for Viral Hemorrhagic Fever (VHF) or other infectious agents on the company's platform. • Preparing buffer reagents to support and optimize RT-PCR conditions. • Optimize sample preparation, real time PCR and RT-PCR assays for the company's platform.  • Apply analytical problem solving skills to reagent and system integration issues to identify critical performance factors. • Handle clinical samples and help perform microbiology work of various micro-organisms and tissue cultures. • Help develop and write verification and validation SOPs and technical reports. • Maintain detailed experimental records. • Present data at weekly technical meetings. • Provide input to the project schedule as required

A biomedical company located in Sunnyvale, CA is seeking a Research Associate to join their infectious disease group. As a Research Associate in the company’s Research Department, you will be involved in the design and construction of prototype assays.  The successful candidate will have experience with molecular biology techniques and be able to work both individually and with a team. You will have the opportunity to interact with many groups at Cepheid and to learn about product development. PRIMARY RESPONSIBILITIES: Literature review Target selection Oligo design and screening PCR assay optimization Preparation of DNA and RNA from various sources Maintain notebooks and records commensurate with the design control requirements of the IVD industry Maintenance of equipment

A biotech manufacturing company in Sunnyvale, CA is looking for a Research Associate to be an integral part of a team developing cutting edge real-time PCR assays for the GeneXpert. Assist and provide support for scientists in the development of novel PCR assays for the detection of organisms from blood stream infections. Duties include performing assay and sample preparation optimization experiments; production of liquid and dry reagent formulations; and maintenance of results database.  Responsibilities:  Perform qualification and quantification of oligonucleotides. Standardize and maintain lab stocks of microbiological cultures and purified nucleic acid test and control materials. Prepare and purify organismal nucleic acid from different sample types, including bio-hazardous clinical samples. Produce accurate, thorough and timely documentation in notebooks, author reports of analytical studies and experiments, and participate in regularly-scheduled project technical meetings.  Receive, catalog, and freeze isolates from a variety of sources for research studies. Optimize reagent formulations. Perform PCR tests for organisms as required. Enter data from experiments into a database. Perform preliminary alignments of DNA sequence data and enter results into database. Maintain notebooks, reports and records. Maintain appropriate inventory of supplies. Maintain and promote a safe working environment.

A biomedical manufacturing company located in Sunnyvale, CA is seeking a regulatory Affairs specialist. The Regulatory Affairs department is responsible for interacting with the US Food and Drug Administration (FDA) and regulatory agencies in over 45 countries across the globe, to submit technical documentation and obtain registration licenses. The Regulatory Affairs department keeps abreast of changes to the regulatory landscape, and formulates a regulatory plan that feeds into the product development process. Demonstrating a product’s safety and efficacy, and successfully registering it with the appropriate regulatory agencies, are prerequisites for selling the company’s products in the US and around the world. As a part of the International Regulatory Affairs group, the Regulatory Affairs Intern will work on a well-defined time-bound project to streamline the company's regulatory documentation processes and to ensure that documents are furnished in a timely manner to international regulatory agencies. Responsibilities include: Review, edit and proofread regulatory documentation Compile, under supervision, regulatory documents for submission Compile and prepare responses to questions from regulatory authorities as required Assist in data entry and database audit of the regulatory affairs database for accurate tracking of regulatory product status worldwide Maintain awareness of regulatory requirements May be responsible for a specific country/project