Manufacturing of cell therapy products.
Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
- Perform manufacturing procedures inside class 10,000 clean room in accordance to established SOPs, cGMPs, and safety regulations.
- Perform aseptic manipulations of cull culture, final product assemblies.
- Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
- Input data from production records to existing databases.
- General housekeeping of manufacturing controlled area.
- Perform clean room equipment sanitization.
- Record equipment metrology readings to ensure the equipment is operating within specifications.
- Interact with other manufacturing groups such as QA, MTS, QC, etc.
- Review completed production records for accuracy.
- Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- High school diploma or equivalent with a minimum of 1 year experience working in a cGMP environment in the biotech or pharmaceutical industry.
- Excellent communication skills, written and verbal.
- Experience with Microsoft Word and Excel.
- Associates Degree (preferably in Life Sciences or related field), Biotechnology certificate or equivalent.
- Will consider relevant experience in lieu of education.
- Experience in small scale tissue culture processing and a minimum of 1 year in cGMP/cGLP environment.
Working Conditions and Physical Demands:
- May be required to sit for long periods of time while performing physical duties.
- Must be able to lift, carry, push and pull up to 50 lbs.
- Able to work a flexible schedule including weekends and/or holidays as required to meet production demands.