Manufacturing Associate I/II/III
528b Eccles Ave South San Francisco, CA 94080
Hours: 3: 30 PM – 2: 00 AM, Schedule: 4 days/week, 10 hours/day
Associate, Manufacturing, Swing Shift
Reporting to the Supervisor, Manufacturing Swing Shift, this role will be a contributing participant on the Manufacturing team. The Associate, Swing Shift Manufacturing will follow defined tasks in the Manufacturing department and will effectively contribute to a team that is ultimately responsible for the processes and manufacturing. The Associate will be present in the production process, meet deadlines and be an active participant in issue reporting and resolution. This position will be located in South San Francisco.
- Perform all manufacturing operations under cGMP/ISO requirements
- Adhere to valid manufacturing procedures and documentation
- Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process
- Maintain a high level of quality and compliance with regards to all aspects of manufacturing
- Operate production equipment, including inspection, set up, processing, and cleaning
- Responsible for receiving activity handoff from Day Shift and continuing to completion
- Execute corrective measures addressing any issues in a timely manner
- Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues. Execute corrective measures addressing any issues in a timely manner
- Ability to contribute to process improvement plans and help drive to completion
- Maintains and follows GMP practices and identifies and escalates potential GMP issues
- Assist in the evaluation and incorporation of new technologies
- Other duties as assigned
- BS in Science or Engineering or equivalent experience
- Associate: 1+ years of experience working in a GMP manufacturing environment
- Associate II: 3+ years of experience working in a GMP manufacturing environment
- Senior Associate: 5+ years of experience working a GMP manufacturing environment
- Displays understanding of upstream and downstream process theory (i.e. Fermentation, Harvest, Tangential Flow Filtration, Column Chromatography, Filling) and equipment operation.
- Strong communicator with ability to work effectively both independently and as part of a team
- Experience in maintaining detailed records and ability to assist in document revisions
- Firm understanding of cGMPS as related to commercial and clinical operations. Assists in identifying and addressing GMP gaps and ensuring cGMP compliance
- Knowledge of aseptic technique, cGMP, or FDA regulations.
- Effective problem-solving skills
- Strong computer skills including MS Office (Word, Excel)
- Ability to support general investigations and CAPA execution.
- Available to work various shifts (Day, Swing, Holidays) and OT as directed by the production schedule
- Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
- Hours: 3: 30 PM – 2: 00 AM, Schedule: 4 days/week, 10 hours/day
- Experience in cell culture and/or protein purification.
- Experienced in startup of a new facility
- Understanding of Clinical and Commercial manufacturing concepts
- Experience with single-use technologies
- Ability to support general investigations and CAPA execution
- Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities
- Technical understanding of a biotech manufacturing facility
- Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders