An opening is available within our internal Manufacturing group for a Manufacturing Technician. The MT is responsible for the manufacture of therapeutic stem cell products under cGMP conditions. MT are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, independently perform laboratory tasks (such as pipetting and product sampling) and conduct routine sanitization tasks to maintain facility and equipment. They are expected to demonstrate a strong understanding of cGMP compliance, while operating under supervision, and aseptic technique in handling of products and materials.
Primary Accountabilities, Duties and Responsibilities
- Set up, operate equipment, monitor production processes and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate.
- Attain qualification for all assigned tasks and maintain individual training plan.
- Demonstrate proficiency at laboratory tasks, such as pipetting, sterile filtering and product sampling.
- Perform material movements, transfer materials and chemicals in, out, and across the production areas.
- Maintain facility and equipment through routine cleaning and sanitization.
- Perform other duties as assigned.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data.
Essential Job Functions
- Must be able to accommodate a flexible work schedule (e.g., late afternoon, weekends and holidays) and regular attendance necessary.
- Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of stem cell products. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions.
- Environmental Demands: The normal working environment is: Production Floor setting, requiring PPE, gowning, safety shoes and glasses.
- Physical Demands: Capable of lifting 40 lbs., unassisted.
Minimum Required Qualifications/Skills
- Education: AS with 2 years biological manufacturing experience; BS preferred
- Preferred area of study: Science related discipline
- Knowledge: Proven logic and decision-making abilities, critical thinking skills.
- Skills: Strong written and verbal communication skills are required.
- Qualities & Attitude: Is able to work as part of a team and is open to and actively seeks out feedback on their performance and translates that feedback into action.
Please send resumes to Julie Joo at Julie@hope.bio