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 overhead
Ability to learn how to operate all types of production equipment (I.e. Autoclave, Dry Heat Oven, )
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.
· Effective Communications
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
Integrity
Doing the right thing – the first Honoring and keeping commitments.
Intensity
Working with speed and focus to deliver the highest quality results – on time.
Involvement
Embracing unique perspectives and treating others with dignity and respect.
Innovation
Biased to improve processes and products to better serve customers and improve
Required Skills and Experience
Readily adapts to changing job duties
Works well in a team environment
Detail oriented
Willing to learn new tasks, skills
Responds quickly to assignments
Positive attitude
Degree or relevant experience in a technical, engineering or science-based discipline
Preferred > 1-year relevant experience in a biopharmaceutical manufacturing facility or equivalent experience in a current Good Manufacturing Practices (cGMP) or technical manufacturing environment
Knowledge of general, technical and manufacturing operations
A proven ability to work as part of a team to deliver results
Organization Skills – Ability to manage multiple priorities and know when to escalate issues for resolution
Effective Communicator
Basic level of understanding with Microsoft Office Products (Word, Excel)
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.AgreeRead Privacy policy
