Target PR Range:

43-53/hr

•Depending on experience The Biologics CMC Development team has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure. This Scientist I role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs. This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.

Responsibilities include:

Scale-up protein purification processes, including Affinity/IEX/HIC/MM chromatography, nanofiltration, depth filtration and ultrafiltration/diafiltration Large scale buffer preparation to support scale-up processes Operate, troubleshoot, and maintain pilot-scale bioprocess equipment such as depth filtration systems, chromatography skids, virus filtration systems, TFF skids, mixers, tanks, pumps, and single-use assemblies Perform pre-run readiness activities, including equipment setup, column packing/qualification, buffer/media verification, and raw material staging Support incoming transfer processes to scale-up lab to support GLP toxicology study material production and outgoing transfer processes to GMP manufacturing site for clinical material production Work efficiently, collaboratively, and cross-functionally toward project timelines and goals Author standard operating procedures (SOPs), technical reports and maintain well-documented records in an electronic lab notebook (ELN) Author and deliver technical presentations

Qualifications Basic:

Bachelor's Degree or equivalent education and typically 5 years of experience and MS or equivalent education and typically 2 years of experience Must have CMC protein purification development experience with standard bioprocess unit operations such as chromatography separations (resin/membrane: affinity, CEX, AEX, HIC, MM) and filtration operations (depth filtration, virus filtration, sterile filtration, TFF) Must have excellent attention to detail and ability to keep detailed written records Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions Demonstrated ability to learn, understand and master new experimental techniques Able to work collaboratively within and outside of the group Able to author technical reports and presentations Has understanding of biochemistry and bioprocess engineering concepts Has strong planning and analytical skills Experience with AKTA chromatographic instruments (such as AKTA Ready, AKTA process, AKTA Avant, AKTA Purifier, AKTA Pure or similar), TFF skids (such as Sartoflow 1000 or similar) Demonstrated scientific writing skills and strong verbal communication skills including scientific data presentations Has proficiency with Microsoft Office software, ability to learn new software applications

Preferred:

Has hands on experience with executing antibody or antibody-like molecule purification techniques including resin chromatography (affinity, CEX, AEX, MMC), depth filtration, virus filtration, membrane chromatography, and TFF operations, preferably at pilot or GMP scale Has hands on experience with unit operation development including cell culture harvest, affinity chromatography, polishing chromatography, virus filtration and ultrafiltration/diafiltration. Understanding of analytical techniques, such as HPLC, LAL, and ELISA Has hands on experience with high-throughput technologies and automation