• CMC Biologics is establishing a new scale-up purification laboratory in South San Francisco.
• The scientist will support lab startup and day-to-day scale-up/pilot purification activities, with significant hands-on responsibility for buffer preparation, chromatography, TFF operations, equipment setup/troubleshooting, SOP development, documentation, and technical reporting.
• The ideal candidate has biologics/protein purification experience in a GMP, pilot, or scale-up environment, preferably with experience spanning purification from harvest through UF/DF and pilot operations around 50 L–1,000 L bioreactor scale.

Ideal Candidate

• A BS/MS-level scientist with hands-on biologics downstream purification experience who has worked in a GMP, pilot, or scale-up environment.
• The strongest profile will have antibody/protein purification experience across multiple unit operations, direct operation of ÄKTA and TFF equipment, pilot-scale exposure, equipment troubleshooting capability, and experience establishing SOPs/documentation in a laboratory setting.

Core Requirements

• BS with approximately 5–7 years relevant experience OR MS with approximately 2+ years relevant experience.
• Degree in Chemical Engineering, Chemistry, Biochemistry, Bioengineering, or related discipline.
• Hands-on CMC/biologics protein purification or related downstream process experience.
• Experience in a GMP facility, pilot laboratory, or scale-up environment.
• Hands-on experience with chromatography and filtration unit operations, including:
• Protein A / affinity chromatography
• Ion exchange chromatography (CEX/AEX/IEX)
• Hydrophobic interaction chromatography (HIC)
• Mixed-mode chromatography (MM) preferred
• Depth filtration
• Virus/sterile filtration
• Nanofiltration
• TFF / UF-DF
• Experience operating larger-scale bioprocess equipment, including chromatography systems and TFF skids.
• Ability to work hands-on in a primarily laboratory-based environment.
• Experience authoring SOPs, technical reports, and maintaining detailed ELN records.
• Strong troubleshooting, experimental design, analytical, planning, and scientific communication skills.

Key Responsibilities

• Perform and support scale-up protein purification processes from harvest through UF/DF.
• Prepare buffers at laboratory/pilot scale.
• Set up, operate, troubleshoot, and maintain chromatography systems, TFF skids, filtration systems, 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 GLP toxicology material production and transfers to GMP manufacturing for clinical material.
• Develop and maintain SOPs for laboratory equipment and processes.
• Document experimental/process activities in ELN and prepare technical reports.
• Present technical findings to project teams/stakeholders.
• Support establishment and operationalization of the new purification laboratory.
• Collaborate cross-functionally toward project timelines and deliverables.

Preferred Experience

• Antibody or antibody-like molecule purification.
• End-to-end purification experience from harvest through UF/DF.
• Pilot-scale experience, preferably 50 L–1,000 L bioreactor scale.
• Recent/current GMP or pilot-lab experience.
• Process development experience, including candidates with primarily bench-scale development experience.
• Hands-on experience with:
• ÄKTA Ready – primary system
• ÄKTA Process
• ÄKTA Avant
• ÄKTA Pure
• Potentially ÄKTA Pilot 600
• Lab startup/setup experience, including equipment installation/setup, SOP creation, and documentation systems.
• HPLC, LAL, ELISA, high-throughput technologies, or automation experience.

Highest priority:

• Recent/current GMP, pilot, or scale-up laboratory experience.
• Hands-on biologics/protein or antibody purification.
• Multiple purification unit operations, ideally harvest through UF/DF.
• Hands-on chromatography: Protein A, IEX, and/or HIC.
• ÄKTA and TFF equipment operation.
• Larger-scale/pilot operations, ideally 50 L–1,000 L.
• Equipment troubleshooting and laboratory setup.
• SOP, ELN, technical report, and presentation experience

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).