Manufacturing Technician II

Job Title

This position is responsible for maintaining fibroblast cell cultures in various platforms to produce Fibroblast Conditioned Media. Collect and sample fibroblast conditioned media and to manufacture solutions used during the cell culture process. Support cell culture activities, such as: assisting with the cleaning and sterilization of all components, containers, and associated equipment used in the production department.

Responsibilities:

• Maintain human fibroblast cell culture of human fibroblast in a clean room environment as directed by manufacturing schedules within standard times and according to established procedures.
• Assist in the manufacture of solutions used in production and processing of raw materials.
• Sample by-products using standard methodologies.
• Complete all relevant documentation compliant with cGMP and GDP guidelines
• Maintenance of the cell culture complex and surrounding environment (i.e. refrigerators, freezer, warm room, etc.)
• Assist in the organization and housekeeping of the washroom and production support areas.
• Assist in the cleaning of autoclavable materials used during cell culture.
• Assist in the maintenance of cell expansion cultures.
• Maintain a clean and safe work area and report unsafe conditions to management.
• Assist in the assembly of cell culture roller bottles
• Perform other duties as assigned

Skills:

• Performs functions associated with cGMP manufacturing operations within the biologics production facility
• Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment.
• Sampling of in process and raw materials, Running glass washer / autoclave, Buffer / media preparation, Equipment preparation (CIP/SIP), Aseptic practices, Column chromatography, Tangential flow filtration

Education:

• Bachelor's degree preferably in a Natural Science, Cell Biology, Biology, Biochemistry, Chemical Engineering or a related field.
• Associate degree from an accredited two-year program with relevant work experience will be considered.
• 1-2 years of relevant experience GMP practices Mechanical skills

Nice to have:

• Experience working with mammalian cell cultures in a cleanroom environment
• Strong understanding of biology, including animal organisms, their tissues, cells and cell-cell interactions and function.
• Intermediate problem-solving attitude
• High level of mathematical skills
• Experience working in a GMP regulated environment
• Aseptic Technique (clean room)

EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."