Technician, Manufacturing

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