This 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.

The 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.

The candidate will support the calibration and maintenance activities required for QC equipment using computerised asset management software.

The candidate will complete and document activities in accordance with CGMPs, SOPs, and protocols.

Perform compendial assays and processing of samples as needed.

Report deviation events to QC management.

This position is essential for ensuring that the laboratory meets the high standards required for CGMP lot release and stability testing.

The role also involves contributing to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation.

The position requires a strong background in laboratory practices, general testing methodology, assay troubleshooting, and familiarity with Quality Systems.

Perform other duties as assigned.

Ability to follow safety procedures outlined in the Safety, Health and Environmental requirements.

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Key Responsibilities:

Perform automated and manual high-throughput processing on the BigHat platform, including DNA preparation, protein expression, and protein characterization. Contribute to the scaling up of BigHat's platform and production-grade data generation. Support BigHat's Platform Reagents & Assay Support (PRAS) function by contributing to in-house reagent manufacturing efforts. Execute experiments to optimize the performance efficiency of BigHat's platform. Keep a detailed record of all experiments using BigHat's documentation tools, and clearly communicate results and challenges. Collaborate on the creation of laboratory standard operating procedures (SOPs) for sample processing. Collaborate closely with BigHat team members to identify, design, and implement critical process and operational improvements to production workflows and laboratory systems. Operate automated liquid handlers and analytical instruments to ensure all lab and platform operations run efficiently.

Skills, Knowledge & Expertise:

BS in Biology or Chemistry, with 1+ year(s) of industry experience Experience in process execution, laboratory method development, optimization, and troubleshooting. Hands-on experience with, or interest in, automated liquid handlers (e.g. Hamilton, OpenTrons, Tecan, Agilent systems). Experience with molecular biology techniques and general lab practices. Efficient time management and ability to work on several projects simultaneously, in a dynamic start-up environment. Strong interpersonal skills and ability to effectively communicate with members of a multidisciplinary team. Excellent record keeping abilities to document experimental work and analytical data. Nice-to-haves include previous experience working with barcoding systems, inventory tracking, and experience with Google Workspace tools (Docs, Sheets, Slides, etc.).

Benefits: The 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. Range of health insurance plan options through Anthem and Kaiser (monthly credit if benefit waived) Dental, and vision coverage through Guardian Additional well-being benefits through Nayya, OneMedical, Wagmo, Rula, and more 401(k) with company match DTO, two weeks of company-wide shutdown, and 12 company holidays Paid parental leave

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