At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing hard scientific problems with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across various disciplines.
We are hiring a Quality Control Scientist, NPI to join our growing Operations team. This role is the bridge between R&D and Operations, and responsible for transferring reagent production and quality control processes from R&D bench processes to commercial operational processes. This will include validating R&D SOPs through hands-on testing of reagents and training the Quality Control team on new SOPs and methods, ensuring that the team can consistently produce high-quality reagents at a commercial scale.
This position requires a full-time onsite presence at our San Carlos, CA location. This position reports to the Sr. Director of Reagent Formulations.
Responsibilities
Supervise the Quality Control team.
Early-stage collaboration with R&D/Development to learn new reagent QC methods and adapt them for volume production.
Manage transition schedules to ensure timely and efficient transfer of QC processes to the Quality Control team.
Hands-on testing of NPI reagents to support R&D experimental requirements before integration of processes into the production team.
Authoring, reviewing, and approval of analytical test methods and quality control SOPs to ensure they are complete and accurate and produce reagents that consistently meet required specifications.
Development of documentation and visual tools to ensure that quality testing steps are readily available to operators for the successful execution of production and quality control processes.
Train the quality team to execute reagent testing processes; ensure operators are qualified on each quality control method.
Collaborate with R&D to plan, design, and execute studies to meet project objectives of shipping, stability, and storage. Occasionally support the production of reagents required for shipping, stability, and storage specifications.
Collaboration with finance and data management to capture costing and QC data throughout the process.
Engage operations engineering to automate QC processes and data processing.
Work with R&D to determine the root cause for analytical test method and production process deviations that lead to reagent defects and variability. Implement corrective actions in a production environment.
Implement equipment maintenance processes and schedules and troubleshoot QC instrumentation as needed.
Contribute to building a culture that embraces scientific excellence, urgency, partnerships with key stakeholders, continuous learning and improvement, and increasing technical skill base; take a proactive role in personal growth and scientific development.
Qualifications
PhD in Molecular Biology, Chemistry, Chemical Engineering or a related field with 6+ years of relevant experience in an NPI or Technology Transfer environment required or BS/MS with 12+ years of experience.
Some supervisory experience required.
Prior experience in scaling reagent production from low R&D volumes to high-volume and automated production.
Experience and ability to perform hands-on quality control of NPI reagents.
Extensive HPLC experience.
Experience with using reagent production and QC equipment is preferred. Such as:
TFF
Absorbance and fluorescence spectroscopy
Gel Electrophoresis
Mass spectrometry
Affinity binding assays (such as ELISA)
Able to demonstrate prior success in working cross-functionally with R&D teams to develop and transition quality control and production processes.
Prior experience with documenting SOP’s and training production personnel.
Track record of developing and validating biochemical and molecular-based processes for commercial product generation.
Broad familiarity with different disciplines within the life sciences ( e.g. PCR, protein expression and purification, chromatography, antibody chemistry and binding kinetics).
Familiarity with tools and methodologies that are commonly used in modern laboratory and production data analysis.
Nautilus Team Culture
We are curious go-getters: this is a team of lifelong learners who aren’t afraid to tackle the big challenges and we embrace the journey.
We are detail-oriented: we do great science by working smart & with diligence and we learn from our trials and mistakes.
We are easy to work with: we want our workplace to be one where everyone can share their perspective and be treated with respect and kindness.
#LI-ONSITECompensation Range: $111K - $162K
