We are seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by playing a crucial role in Quality Control Operations including sample management, equipment management and reagent management in the AstraZeneca Quality Control Laboratory.
\nThis position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations. The candidate will be primarily responsible for the receipt, storage, inventory, and distribution and preparation of samples, controls, reagents and standards used in analytical testing, utilizing paper and computer-based inventory systems.
\nThe candidate will also be responsible for the operation, organization and maintenance of Temperature-Controlled Storage Units and ensure that samples, reagents, standards and controls are stored in appropriate temperature conditions utilizing paper and computer-based asset systems.
\nThe candidate will support the calibration and maintenance activities required for QC equipment using computerised asset management software.
\nThe candidate will complete and document activities in accordance with CGMPs, SOPs, and protocols.
\nPerform compendial assays and processing of samples as needed.
\nReport deviation events to QC management.
\nThis position is essential for ensuring that the laboratory meets the high standards required for CGMP lot release and stability testing.
\nThe role also involves contributing to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation.
\nThe position requires a strong background in laboratory practices, general testing methodology, assay troubleshooting, and familiarity with Quality Systems.
\nPerform other duties as assigned.
\nAbility to follow safety procedures outlined in the Safety, Health and Environmental requirements.
\nXML job scraping automation by YubHub
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\nKey Responsibilities:
\nPerform automated and manual high-throughput processing on the BigHat platform, including DNA preparation, protein expression, and protein characterization.\nContribute to the scaling up of BigHat's platform and production-grade data generation.\nSupport BigHat's Platform Reagents & Assay Support (PRAS) function by contributing to in-house reagent manufacturing efforts.\nExecute experiments to optimize the performance efficiency of BigHat's platform.\nKeep a detailed record of all experiments using BigHat's documentation tools, and clearly communicate results and challenges.\nCollaborate on the creation of laboratory standard operating procedures (SOPs) for sample processing.\nCollaborate closely with BigHat team members to identify, design, and implement critical process and operational improvements to production workflows and laboratory systems.\nOperate automated liquid handlers and analytical instruments to ensure all lab and platform operations run efficiently.
\nSkills, Knowledge & Expertise:
\nBS in Biology or Chemistry, with 1+ year(s) of industry experience\nExperience in process execution, laboratory method development, optimization, and troubleshooting.\nHands-on experience with, or interest in, automated liquid handlers (e.g. Hamilton, OpenTrons, Tecan, Agilent systems).\nExperience with molecular biology techniques and general lab practices.\nEfficient time management and ability to work on several projects simultaneously, in a dynamic start-up environment.\nStrong interpersonal skills and ability to effectively communicate with members of a multidisciplinary team.\nExcellent record keeping abilities to document experimental work and analytical data.\nNice-to-haves include previous experience working with barcoding systems, inventory tracking, and experience with Google Workspace tools (Docs, Sheets, Slides, etc.).
\nBenefits:\nThe salary estimated for this position is $75,000 - $105,000 + bonus + options + benefits. Compensation will vary depending on job-related knowledge, skills, and experience. Actual compensation will be confirmed in writing at the time of the offer.\nRange of health insurance plan options through Anthem and Kaiser (monthly credit if benefit waived)\nDental, and vision coverage through Guardian\nAdditional well-being benefits through Nayya, OneMedical, Wagmo, Rula, and more\n401(k) with company match\nDTO, two weeks of company-wide shutdown, and 12 company holidays\nPaid parental leave
\nXML job scraping automation by YubHub
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