Manufacturing Associate II - Purification
Oakland-Fremont-Pleasanton Metro Area, CA
- Purifies proteins in a regulated FDA licensed & ISO certified facility.
- Performs cross-functional activities associated with downstream production runs in collaboration with Bulk Fill & QC testing groups.
- The role may include special projects such as process development & validation activities where scientific research principles are applied.
- Works as part of the purification team to perform purification, filtration, & centrifugation operations according to standard operating procedures (SOPs).
- Executes laboratory operations that include dispensing of chemicals, volumetric & gravimetric measurements, making accurate dilutions, & preparing solutions.
- Performs equipment maintenance tasks, column packing, & column testing procedures.
- Ability to multi-task & become proficient at purification & conjugation.
- Analyzes in-process samples & understands how to apply the information to process control & quality monitoring.
- Operates lab equipment such as pH meters, balances, centrifuges, spectrophotometers, HPLC systems, & densitometers
- Complies with cGMP & ISO requirements.
- Maintains accurate documentation related to manufacturing processes.
- Must have knowledge of protein purification processes
- Experience following & writing SOPs.
- Experience with preparation of reagents following manufacturing SOPs.
- Knowledge of SAP, Kaizen, & 5S is desirable.
- At least 2 years of experience with a BA/BS in a GMP environment.
- Six years of relevant experience can substitute for a degree in the sciences.
- BA/BS in the Sciences (Biology, Engineering, or related field)