Excellos Co-Op Program Manufacturing Associate I Cell Therapy
This position is part of the UC San Diego Division of Biological Sciences Co-Op Program. Visit here for more information. Students must take a professional development boot camp taught by UC San Diego faculty and staff prior to starting their Co-Op position in summer.
If you have questions, contact the Co-Op Program staff advisor (mhoon@ucsd.edu).
Department: Cell Therapy
Reports to: Cell Therapy Lab Supervisor
Job Summary
The Cell Therapy Manufacturing Associate I is responsible for completing and assisting with daily tasks associated with the production of various cellular products in a clean room manufacturing environment. The Associate will be responsible for maintaining and working in controlled, supportive laboratory areas and potentially maintaining and working in cGMP ISO7 and ISO8 manufacturing spaces, as well as certified ISO5 biosafety cabinets. The Associate will be responsible for participating in the maintenance of critical supplies, equipment, product testing, product storage and product distribution.
Responsibilities
· Adheres to good manufacturing practices (GMP) guidelines.
· Maintains client confidentiality as required.
· Supports manufacturing of cell products in a clean room environment, following proper gowning protocol and using aseptic technique.
· Expected to follow facility-defined gowning qualification, contingent upon relevant training and competency assessments.
· Maintains the clean room environment following cleaning procedures and including implementation and support of environmental monitoring processes defined by the facility.
· May participate in manufacturing of Research Use Only products, following Batch Production Records (BPRs) and Standard Operating Procedures (SOPs), contingent upon relevant training and competency assessments.
· Understands and documents detailed manufacturing steps per BPR and recognizes when deviations or incidents are to be documented.
· Supports and participates in research and investigational studies.
· Provides feedback and support in department development/process improvement.
· Supports the Excellos safety, GMP and Quality Plan.
· Participates and assists in the maintenance of equipment and supplies in support of manufacturing.
· Assists with the order and release of critical manufacturing materials to meet changes in production demand.
· Maintains department records, reports and statistical data, as required.
· Initiates Quality Incident Reports and Deviations, as required.
· Cryopreserves, stores and distributes products per BPRs/SOPs.
· Performs colony forming units assay procedures (CFUs), performs cell counts (using various methods), sets up samples for sterility testing, performs flowcytometry assays for viability and cell identification.
· Participates in department meetings and educational programs.
· Participates in proficiency testing.
Working Environment
· Normal laboratory environment with biohazard precautions.
· May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
· May be exposed to hazardous chemicals.
· Will be working with liquid nitrogen.
· May be called on to workdays or hours other than routinely scheduled hours, work overtime hours, or potentially work through breaks, if necessary.
Physical Requirements
· Must be able to stand long hours.
· Must be able to sit for long hours, potentially while working in a biosafety cabinet.
· Must be able to communicate clearly.
· May be required to lift up to 50 pounds.
Equipment Used
· Laboratory processing equipment (examples include, but are not limited to: centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, cell counters, flow cytometers, incubators, cell separators).
· Normal office equipment such as: telephone, computer, cell phone, printer, copier, fax, scanner.
· General laboratory equipment (examples include, but are not limited to: barcode scanners, scales, shippers, refrigerators, freezers).
Qualifications
Education:
o Undergraduate in Biology, Cell Biology, or life science related field.
Experience:
o None required
Skills:
o Understanding of aseptic technique and Good Manufacturing Practices (GMP).
o Must be able to perform calculations such as cell concentrations, dilutions, percentages, weight measurements and volumes.
o Ability to organize information for multiple, concurrent projects.
o Interpersonal skills to establish and maintain professional relationships both internally and externally.
o Critical thinking, creativity and innovative thinking.
o Detail oriented with the ability to set priorities and organize daily work requirements.
o Must be able to work both as a team member and independently, as required.
o Proficient in professional communication both written and oral, which is clear and precise.
o Must keep Management informed on any technical and/or operational issues that arise.
o Must be flexible, as production priorities, timelines, and processes can change regularly.
o Integrity and discretion – ability to maintain confidentiality.
o Ability to perform under pressure and work under stressful situations.
Certifications/Licenses:
o None required
The above statements are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.