Pay Range: $ 41.26/Hr to $ 44.21/Hr
Development Associate II to Associate Scientist - USP/DSP, Biologics Pilot Lab
Working Hours: Mon-Fri typical business hours (8am-5pm). Occasional weekend work will be necessary.
Role:
Seeking motivated, team-oriented individuals with expertise and experience in cell culture and/or protein purification process development and/or scale-up to support our pre-pivotal purification & pilot operations group. This is an opportunity to work in teams for the early- and late-stage development of biological molecules.
Specific Responsibilities:
- Plan and execute assigned tasks that support upstream cell culture and downstream purification operations.
- Monitor and evaluate process performance data, report and present findings, and proactively seek out senior personnel to discuss potential solutions to problem.
- Work with group members to maintain the lab, including analytical equipment maintenance, inventory and stocking support, and general lab upkeep activities.
- Participate in group meetings and present results, data interpretation and conclusions.
- Demonstrate strong verbal communication and interpersonal skills including the ability to explain processes used to achieve results of assigned tasks.
- Work with team oriented, collaborative and problem-solving mindset.
- Always work with safety in mind.
Knowledge, Experience and Skills:
- Familiar with cell culture operations, including shake flask and aseptic work in biosafety cabinets, Wave bioreactors, and large scale Single Use Bioreactors
- Hands on experience with reactor sampling and daily monitoring of processes is preferred.
- Familiar with downstream purification process, which includes centrifugation, chromatography, and dead-end as well as tangential filtration.
- Hands-on experience of AKTA, Tangential flow filtration and depth filtration is preferred. AKTA and UNICORN programming: a huge plus, not a must as it is trainable (yet needs experience with other Chromatography operations (e.g. how it works, how to pack resins in columns of various sizes)
- Knowledge of current Good Manufacturing Practices (cGMPs), technology transfer, and scaling up bioprocesses is a plus.
- Must be able to work effectively in cross-functional teams.
- Must demonstrate excellent technical writing skills: strong verbal communication and interpersonal skills.
- Must be self-motivated, organized, and enjoy scientific investigation and thinking.
- Clinical commercial manufacturing or pilot time activities + manufacturing.
Production/Material generation experience in either a Biologics Pilot Lab or a GMP Clinical Facility is the best match (process engineering not the right fit here). This biologics pilot lab in Foster City is not a GMP lab.
Education Requirement:
- AA/AS degree: must have 2+ year relevant industry experience (cell culture and/or purification techniques) or
- BS/BE degree in Chemical/Biochemical Engineering, Biochemistry, Biology, or a related scientific discipline: at least 1 years of experience required (in cell culture and/or purification techniques).
Other Info:
- Team: currently 5 scientists responsible for generating materials to support biologics programs at the pilot scale; conducting troubleshooting and process improvement; assessing and implementing new technology to enable improvement of site-wise operational capability, capacity, and efficiency.