Research Assistant: Reagent Manufacturing
Menlo Park, CA
Temp until end of December
Monday - Friday Day shift
We are seeking a Reagent Manufacturing and QC Development Assistant to join the join the Systems Integration group in the R&D division. We are looking for a talented, motivated, and driven individual to join a collaborative effort to enable development of rapid diagnostic tests.
You will assist in reagent manufacturing and support studies to establish QC specifications and test method qualification. You will also work collaboratively with other departments, including the scientific team in Assay Development, Operations and Quality.
Specific responsibilities include, but are not limited to:
- Perform reagent manufacturing per established procedures
- Maintain thorough batch records and documentation
- Support studies to establish quality control metrics and associated specifications for raw materials, intermediate reagents
- Assist in the preparation and shipment of reagents to contract manufacturers
- Support test method development and qualification
- Assist in drafting and review of work instructions and batch records
- Identify and report production issues promptly to supervisor
- Assist in instrument Installation Qualification, Operational Qualification and Process Qualification
- May participate in process validation activities
- Work productively and cooperatively with Assay Development scientists as well as Operations and Quality.
- Comply with Quality Management System policies and procedures
Education & Experience
- BS or equivalent in Molecular Biology, Chemistry, Biochemistry, Genetics or a related field with 1-2 years of experience.
- Ability to follow instructions and perform procedures accordingly is essential
- Experience in reagent preparation and handling in lab setting or manufacturing environment is required.
- Manufacturing experience in cGMP environment is highly desired
- Experience in operating basic biolab equipment such as pipetter, balance, pH meter, thermocyclers, and Microplate reader, etc., is required
- Proficency in MS Office or other productivity tools is required
- Knowledge of basic statistical skills is required
- Effective written and verbal communication skills
- Experience with polymerase chain reaction (PCR) and real-time PCR (qPCR) a plus
- Experienced in automated liquid handling workstations and related process development a plus.
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