Bioreactor Process Specialist (Biotech)
Position Overview: This position is responsible for maintaining fibroblast cell cultures in a bioreactor process to produce Cell Conditioned Media (CCM). Collect and sample CCM. Assist management in the completion of all relevant documentation compliant with cGMP and GDP guidelines. Actively involved in Technology Transfer Team, which includes technology transfer via written process transmittals and on-site support to the upstream manufacturing team.
Main Areas of Responsibilities:
- Responsible for the initiation and maintenance of human fibroblast cells grown in a bioreactor process inside a cleanroom environment.
- Responsible for sampling of by-products using standard methodologies and established procedures.
- Responsible for the manufacture of solutions and medium used to initiate and maintain cell cultures.
- Responsible for the training of new technicians in all relevant areas of production.
- Responsible for completing all relevant documentation compliant with cGMP and GDP guidelines.
- Perform root cause investigations and complete deviation investigation reports.
- Monitor and troubleshoot bioreactor challenges to establish cellular process parameters and perform data analysis to support production and technology transfer.
- Perform turn-around, cleaning and assembly of 15L bioreactors and related tubing components.
- Operate equipment: pH meters, analytical scales, incubators, YSI biochemistry analyzer, process pumps, automated cell counters.
- Assist in the creation and revision of SOPs.
- Assist with managing inventory of supplies, raw materials and product.
- Maintain a clean and safe work area and report unsafe conditions to management.
- Working knowledge of aseptic techniques and methodologies relevant to cell culture.
- Working knowledge of bioreactor operation in a biomanufacturing environment using mammalian cell lines.
- Understanding of biochemistry
- Ability to perform detailed tasks and document activities accurately.
- Ability to work and communicate with others in a professional manner, within a team-oriented environment.
- Strong written and verbal communication skills and problem-solving abilities.
- 3+ years experience in mammalian cell culture using spinner vessels and stirred tank bioreactors, preferably with Applikon technology, and microcarrier cultures using Fibroblast cells.
- Bachelors degree preferably in a Natural Science, Cell Biology, Biology, Biochemistry, Chemical Engineering or a related.
- Strong understanding of biology, including cell physiology and cell culture parameters in bioreactor and spinner vessels processes
- Experience working in a GMP regulated environment.
Experis is an Equal Opportunity Employer (EOE/AA)