Quality Control Associate Scientist

Founded in 1985, Gemini Bio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.

The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers’ manufacturing workflows – regardless of batch size.

Located in West Sacramento, California, Gemini Bio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company’s cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing. Gemini Bio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

The Quality Control (QC) Associate Scientist reports to the Quality Validations Specialist within the Quality Department and supports analytical assays and tests performed in the QC laboratory while developing subject matter expertise (SME). This role supports the design and execution of assay validation studies, assists in optimization of existing assays, and participates in the development and execution of equipment qualification protocols (IQ/OQ/PQ) under supervision.

In addition, this position supports the execution and monitoring of stability study protocols, including stability testing activities, sample storage and inventory management, and preparation of interim and final reports for internal and external stakeholders. This role also participates in investigations related to out-of-specification (OOS) results and other quality events within the department under guidance. Strong written and verbal communication skills are required, as this position involves cross-functional collaboration and reporting of scientific and technical findings while developing the experience necessary to perform responsibilities independently.

• Support the design, development, and implementation of new processes and procedures within the Quality Control department
• Assist in the development and execution of analytical methodologies for in-process testing and final product evaluation
• Contribute to product specification development, validation activities, and equivalency studies under supervision
• Support specification justifications and associated validation or equivalency justification reports
• Support implementation of statistical process control for Quality Control testing activities
• Participate in method transfers and assist in training QC staff as qualified
• Assist in the preparation and execution of stability testing protocols, including drafting interim and final reports and overseeing the storage and inventory management of stability study samples.
• Support analytical method and process development projects under guidance
• Assist in development and execution of IQ/OQ/PQ and calibration protocols for analytical equipment
• Ensure documentation related to analytical methods and processes is accurate and maintained within the QMS
• Collaborate with cross-functional teams to support analytical and process improvements
• Participate in laboratory investigations and support root cause analysis activities
• Maintain working knowledge of applicable SOPs related to testing, review, equipment calibration, and maintenance
• Support compliance with ISO 13485 and the Company’s quality objectives
• Perform other duties as assigned

• Customer Centric
  • Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience. Able to identify barriers and inefficiencies impacting customer value.
• Effective Teamwork
  • Keen ability to collaborate with a diverse set of colleagues – often under pressure – to accomplish business objectives and deliver customer value. Able to identify – and correct – the issues degrading the success of…