Scope of responsibility:
The Tech III position will be a primary entry point for GMP Manufacturing of biologics at the Carlsbad site and a promotion from Tech I/Tech II. Differentiation on Tech level will be based on experience levels in GMP Manufacturing at both the Carlsbad site and at external locations. These positions do not have supervisory responsibility. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, and Managers). Employees will have no specific decision-making authority as they are asked to follow GMP batch records. Employees are expected to prepare suites for manufacturing, to document deviations, and to operate in a safe manner for the employee, others in the GMP Manufacturing suites, and for the Product being manufactured.
PURPOSE OF THE POSITION
The Manufacturing Biologists (Tech III) in the Operations department are responsible for performing mammalian cell culture, buffer and medium preparation, membrane clarification, TFF (UFDF) concentration and buffer exchange, column purification, terminal filtration, Fill and Finish, stocking supplies and raw materials, and cleaning in process equipment. Responsible for setting up and operating Bioreactors (Applikon, Wave, SUB), and large scale Purification equipment (BioProcess skid). Manufacturing Biologists are responsible for drafting Batch Production Records and Standard Operating Procedures. Provide supervision for GMP operations as necessary. Manufacturing Biologists will be progressively developing competency in cGMP manufacturing of biopharmaceuticals and will be trained towards proficiency in all unit operations including; Project Leadership and Project Planning. Manufacturing Biologists are to assist in the training and development of Manufacturing Technicians.
Essential Job Functions
Essential Functions:
Troubleshooting equipment and process failures
Recognize common equipment failures and process anomalies
Assist in Deviation Investigations, Corrective Action, Preventative Action, and Document Training.
Author Document Change Requests for Batch Production Records, Standard Operation Procedures, Item Specifications, and Qualifications.
Leadership
Reinforce cGMP documentation guidelines
Emphasize importance of quality cGMP compliant documentation to coworkers
Provide on-the-job training, emphasizing cGMP compliance
Provide a positive reinforcing, open learning atmosphere
Tailor training style to meet individual needs
Set a good example in observance of cGMP and Quality
Follow up on instructions/suggestions to ensure compliance
Demonstrate leadership by example and participation
Compliance with safety guidelines
Use safety eyewear while inside a manufacturing area
Know appropriate emergency response procedures
Know locations of first aid kits, safety showers, and spill kits
Know evacuation route and assembly area to be used in case of fire or earthquake
Know the location of MSDS binders and understand how the guidelines pertain to operations
Follow good chemical safety practices
Comply with all cGMP Documentation and procedures
Record information accurately
Make corrections in a timely manner
Check all necessary calculations
Review pre-recorded data for accuracy and completion
Ensure all entries are neat and legible
Understand operator and verifier responsibilities
Review labels and equipment calibrations prior to use
Perform preliminary review of completed documentation
Keep logbooks updated and accurate
Comply with cGMP Practices and Regulations
Generate clear and concise labels for all in-process equipment and materials
Understand, observe, and practice proper gowning
Understand flow of materials and personnel in the manufacturing areas
Maintain clean and well-stocked labs
Compliance with Policies and Regulations
Compliance with 21 CFR - Parts 210 and 211