Position: Manufacturing Associate I-IV

Class: Non-Exempt

Reports to: Director of Manufacturing

Location: West Sacramento, CA

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 Associate will work within the Manufacturing Department and be responsible for daily execution of tasks associated with the manufacture of products produced by GeminiBio in accordance with cGMPs. Our products are made aseptically and are sterile-filled following cGMPs. In addition, this person may be asked to assist, and/or perform tasks outside of direct product manufacturing, such as cleaning the manufacturing spaces or to execute maintenance, calibration or validation protocols. This person will be expected to follow, and at times write and implement 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 always be expected to collaborate as a team player with personnel in EHS, Engineering, Supply Chain, Quality Control, Quality Assurance and Information Technology to effectively perform duties of manufacturing within GeminiBio.

Key Responsibilities

• Abide by all safety requirements as defined by the company
• Read and follow all Company SOPs and guidelines
• Document all work as required by cGMPs on a real time basis
• Assist with or lead Deviation investigations/closures, CAPA closures or Change Controls
• Assist with clean room sanitization as required

• Pass and sustain aseptic qualifications which consist of passing gown qualification, maintaining gown access, passing Grade A qualifications, passing media fill qualifications, and perform Environmental monitoring during aseptic filling
• Perform aseptic production operations and validations
• Assist with facility and process validations as required
• Assist with facility cleaning, operational maintenance or calibration
• Production, filling and inspection of manufactured formulations
• All other task assigned by direct supervisor
• Basic knowledge of the Scientific Method
• Basic math skills, including simple algebra
• Basic knowledge of and adherence to cGMP
• Basic knowledge of chemistry and biology
• Basic knowledge of steam/dry heat sterilization theories
• Basic knowledge of OSHA Safety requirements
• Basic level of mechanical aptitude
• Good documentation skills
• Ability to lift / move 40 lbs. overhead
• Ability to learn how to operate all types of production equipment (I.e. Autoclave, Dry Heat Oven, etc.)
• Ability to read, understand and accurately follow company SOPs and guidelines
• Displays understanding of and promotes company and customer objectives

Core Competencies

• 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 teams.

·         Personal Leadership

• • 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

• • 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.