Company Profile

Founded in 1985, GeminiBio 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, GeminiBio 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.

GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

Position Summary

The Manufacturing Technician will work within the Operations Department and be responsible for daily execution of supports tasks associated with the manufacture of cell culture products produced by Gemini in accordance with cGMPs. Our products are made aseptically and are sterile-filled following cGMPs. This candidate will perform tasks outside of direct product manufacturing, such as cleaning the manufacturing spaces, product labelling, autoclaving, and glassware maintenance. This person will be expected to follow standard operating procedures (SOPs), work instructions (WIs), and device history records (DHRs) following FDA, USDA, and/or other applicable international guidance documents. This person will be expected to collaborate as a team player with personnel in EH&S, Engineering, Supply Chain, Quality Control, Quality Assurance, and Information Technology to effectively perform duties of manufacturing within Gemini.

Key Responsibilities

• Prepares supplies needed in manufacturing, including autoclave and glassware
• Maintains glassware for the manufacturing floor; washes, rinses, dries, distributes, and stores glassware
• Responsible for preparation and sterilization of manufacturing solutions, and buffers
• Manages media preparation workflow to meet or exceed turn-around-time expectations
• Uphold safe practices and work environment
• Manual dexterity and be able to repetitively grip and manipulate bottles and lids.

• Assist in maintaining good working conditions in the manufacturing area, general cleaning, organization, receiving, inventory, stocking core solutions and media and office supplies
• Keeping track of needed chemicals and production supplies
• Follow established protocols for routine tasks
• Performs clean room sanitization
• Assist with facility cleaning, operational maintenance and/or calibration
• Supports labelling and sealing of manufactured products
• With proper training, performs Heat inactivation
• Disposal of biohazardous waste and hazardous chemicals
• All other task assigned to you by direct supervisor

Core Competencies

1. 1. • 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

1. 1. • • 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 teams.

·         Personal Leadership

1. 1. • • Consistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives. Strong level of personal accountability. Invests time and energy into professional development. Routinely takes the initiative to solve challenges and capitalize on business opportunities.

·         Planning and Organizing

1. 1. • • Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result. Consistently able to foresee challenges and barriers to success and then effectively develops – and implements – actions to accomplish objectives.

·         Effective Communications

1. 1. • • Able to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management. Oral and written communications are professional and appropriate for the setting and the audience.

Company Values

Innovation

Biased to improve processes and products to better serve customers and improve workflows.