What are the responsibilities and job description for the Operations Technician - Cryopreservation position at Cryoport Systems?
Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.
Cryoport IntergiCell Cryopreservation unleashes cell therapy productivity by turning cryopreservation into a competitive advantage, offering an integrated set of GMP services in line with regulatory, quality and GMP requirements of cell therapy industry which uniquely combines expertise in CRYO-biology, Cell Therapy Production and Bio-logistics.
Position Summary
The Operations Technician is responsible for the production of Cell therapy starting material, cryopreservation, and associated preparation of daily manufacturing activities according to Standard Operation Procedures (SOPs) in a controlled cGMP facility.
This role will execute Leukapheresis cryopreservation processes and will be required to strongly collaborate with fellow Technicians, MSAT Engineers, Quality Control, Procurement, Quality Assurance, and Maintenance teams.
Primary Responsibilities include, but are not limited to:
- Perform and understand detailed processes
- Perform in-process testing, as required by processes and procedures utilizing instrumentation, such as cell counter
- Knowledge and understanding of test methods and interpretation of results
- Verify and enter production parameters per SOP and Batch Records
- Accurately complete documentation in batch records, logbooks, forms and other GMP documents
- Assure manufacturing facility and equipment meets all requirements prior to production on all shifts
- Clean, prepare and assemble equipment for processing operations
- Operate and troubleshoot equipment in clean room and non-clean room environment
- Monitor environmental conditions inside and outside classified rooms
- Perform material transactions, moves, quantities and cycle counts
- Responsible for being trained to assigned curriculum (s)
- Knowledge of cGMP requirements to ensure adherence to compliance policies and regulations
- Wearing the appropriate PPE when working in manufacturing and other hazardous working environments
- Proactively maintaining a clean and safe work environment by performing sanitizing and housekeeping duties and seeking opportunities for improvement.
- Taking necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors
- Performing other work-related duties as assigned
Competencies & Personal Attributes
Technical skills:
- Cell therapy technology knowledge
- GMP / GTP knowledge
- QMS knowledge
- Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment is required
- Knowledge of operating in a clean room environment is required
- Possess the knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment
- Able to assist, or may lead troubleshooting of, routine manufacturing equipment and processes and notify supervisors of any issues
- Able to identify discrepancies or trends that might need additional attention and notify supervisors of any issues.
- Able to work with blood, blood products and chemicals
- Strong communication skills, both verbal and written
Personal Skills:
- Excellent organizational skills with a strong sense of priorities
- Flexible and comfortable in a fast-changing environment
- Good problem solving and time management skills
- Self-starter while being able to act autonomously
- Team player and collaborative mindset
- Customer and solution oriented
- Demonstrated interest in learning
Qualifications And Education Requirements
- Bachelor’s degree in Chemistry, Biology or a related field of study OR
- 2 years’ experience in Cell Processing OR
- 5 years pharmaceutical manufacturing in a GMP facility can be substituted for degree
Compensation: up to $30 hr., commensurate with experience
Cryoport is an Equal Opportunity Employer offering competitive compensation with a generous benefits package that includes health insurance, a 401K with company match and stock equity (Nasdaq: CYRX).
To learn more about Cryoport Systems, please visit https://www.cryoport.com/
Job Type: Full-time
Pay: Up to $30.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
Work Location: In person
Salary : $30