Downstream Process Development Scientist

Position Title: Downstream Process Development ScientistLength of Initial Contract: 6 months, possible extensionLocation/Site: South San Francisco, CA 94080What are the top 3-5 skills, experience or education required for this position:BS with 5-7 years, or MS with 2-5 years; degree in Chemical Engineering, Chemistry, Biochemistry or related disciplineHands on experience with mAb purification unit operations, including Affinity/IEX/HIC chromatography, nanofiltration, ultrafiltration/diafiltration, preferably with scale-up or GMP manufacturing; experience with scale-up equipment such as AKTA Ready/Process, single use mixers, TFF skidsExperience authoring standard operating procedures (SOPs) and reports, and maintaining well-documented records in an Electronic Lab NotebookJob Description: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.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.Responsibilities include: Scale-up protein purification processes, including Affinity/IEX/HIC/MM chromatography, nanofiltration, depth filtration and ultrafiltration/diafiltrationLarge scale buffer preparation to support scale-up processesOperate, 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 assembliesPerform pre-run readiness activities, including equipment setup, column packing/qualification, buffer/media verification, and raw material stagingSupport 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 productionWork efficiently, collaboratively, and cross-functionally toward project timelines and goalsAuthor standard operating procedures (SOPs), technical reports and maintain well-documented records in an electronic lab notebook (ELN)Author and deliver technical presentationsQualificationsBasic:Bachelor’s Degree or equivalent education and typically 5 years of experience and MS or equivalent education and typically 2 years of experienceMust 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 recordsDemonstrated ability to independently design, execute and interpret critical experiments to answer scientific questionsDemonstrated ability to learn, understand and master new experimental techniquesAble to work collaboratively within and outside of the groupAble to author technical reports and presentationsHas understanding of biochemistry and bioprocess engineering conceptsHas strong planning and analytical skillsExperience 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 presentationsHas proficiency with Microsoft Office software, ability to learn new software applicationsPreferred: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 scaleHas 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 ELISAHas hands on experience with high-throughput technologies and automationFor information on benefits, equal opportunity employment, and location-specific applicant notices. 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