Contractor Process Development Associate (Associate Scientist/ Scientist I)

The Contractor Process Development Associate (Associate Scientist/Scientist I) at Allakos is responsible for downstream process development of monoclonal antibodies. They will utilize various techniques to purify protein from harvested cell culture fluid and contribute to tech transfer and manufacturing oversight of contract development manufacturing organizations (CDMOs). The successful candidate will work closely with other teams such as Upstream Process Development, Process Analytics, and DS Manufacturing, and may also provide support to Drug Product Development, Quality, and Process Validation. This position offers the opportunity to join a fast-paced company with multiple studies expected to read out in 2023.

• Work effectively within the purification team to plan, design, and execute experiments supporting downstream process development, optimization, and characterization
• Use various chromatography techniques, normal and tangential flow filtration, etc.
• Prepare reagents and buffer solutions
• Document all work in clearly written and well-organized electronic lab notebooks
• Author downstream process development study protocols and reports
• Review study protocols, reports, and manufacturing batch records
• Contribute to tech transfer and manufacturing oversight of CDMOs
• Analyze and present results in group and departmental meetings
• Keep line management appraised of activities and escalate as appropriate
• Maintain key lab instrumentation and raw materials and consumables inventory
• Interact with Upstream Process Development, Process Analytics, DS Manufacturing, Drug Product, Process Validation, and Quality teams.

• Experience in downstream process development of monoclonal antibodies
• Knowledge and proficiency in various chromatography techniques, normal and tangential flow filtration, etc.
• Ability to prepare reagents and buffer solutions
• Strong documentation skills, including maintaining electronic lab notebooks
• Experience in authoring downstream process development study protocols and reports
• Familiarity with reviewing study protocols, reports, and manufacturing batch records
• Knowledge of tech transfer and manufacturing oversight of contract development manufacturing organizations (CDMOs)
• Ability to analyze and present results in group and departmental meetings
• Strong organizational and communication skills
• Proficiency in maintaining lab instrumentation and inventory of raw materials and consumables
• Collaboration and coordination with various teams including Upstream Process Development, Process Analytics, DS Manufacturing, Drug Product, Process Validation, and Quality teams.

• Competitive hourly rate range of $50 - $60 per hour
• Opportunity to work in a dynamic and changing corporate environment
• Ability to work independently and deliver high-quality results on tight timelines
• Access to well-organized electronic lab notebooks for documenting work
• Authorship of downstream process development study protocols and reports
• Reviewing study protocols, reports, and manufacturing batch records
• Contribution to tech transfer and manufacturing oversight of CDMOs
• Opportunity to analyze and present results in group and departmental meetings
• Interaction with various teams including Upstream Process Development, Process Analytics, DS Manufacturing, Drug Product, Process Validation, and Quality teams
• Maintenance of key lab instrumentation and raw materials and consumables inventory
• Opportunity to gain hands-on experience using AKTA, Avant, and Unicorn programming
• Experience in biologics process development and manufacturing, technology transfer, scale-up of bioprocesses, and cGMP practice
• Excellent written and oral communication skills
• Prior experience in analytical operations such as ProA-HPLC, SEC-HPLC, CE (R/NR), HCP and DNA assays is a plus
• Familiarity with viral clearance concept is a plus
• Familiarity with statistical design of experiments (DoE) and JMP is a plus
• Opportunity to work for an equal opportunity employer that considers all qualified applicants for employment without discrimination on various grounds