Downstream Process Development Scientist

Position Title: Downstream Process Development Scientist

Length of Initial Contract: 6 months, possible extension

Location/Site: South San Francisco, CA 94080

What 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 discipline

Hands 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 skids

Experience authoring standard operating procedures (SOPs) and reports, and maintaining well-documented records in an Electronic Lab Notebook

Job 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/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

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