Manufacturing Associate II, Downstream - San Diego, CA

Manufacturing Associate II - Downstream, San Diego, CA

  • Work is performed in a cGMP manufacturing environment.
  • Assumes lead role in various biological purification projects.
  • Responsible for specific product-related operations in protein purification.  Functions as a Subject Matter Expert for manufacturing.
  • Operates and maintains production equipment with single-use materials as it relates to harvest and protein purification (chromatography columns, depth filtration, cassette and hollow fiber-based ultrafiltration equipment, UV monitors, pH/conductivity, viral filtration, AKTA skids).
  • Proposes, plans, organizes and executes manufacturing in production-scale protein manufacturing.
  • Conduct activities in support of production schedules as directed by senior staff.
  • Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs and Batch Records.
  • Provides detailed observations, analyzes data and interprets results.  Communicates these results to staff and upper management.
  • Initiates deviations, assesses product quality impact and proposes and executes Corrective and Preventative Actions (CAPA).
  • Writes, reviews and approves SOPs, Master Batch Records and other cGMP documentation.
  • Change owner for implementation or revision of equipment, documentation and material specifications.
  • Prepares technical reports, batch summaries, protocols, batch records, specifications and quantitative analyses.
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Reviews completed Production, Buffer and Purification batch records on a daily basis for cGMP compliance and completeness.
  • Supports multiple projects simultaneously.
  • Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
  • May cross-train on various tasks including Upstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
  • Develops effective working relationships with both internal and external partners.
  • Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
  • Provides feedback to Senior Management.

Job Requirements:

  • Bachelor's degree (BA/BS) in Biology, Chemistry or a scientific related field.
  • Minimum of two (2) years of experience in a cGMP manufacturing/laboratory environment.
  • Knowledge of purification process steps including harvest, column packing, chromatography, UF/DF and nanofiltration as well as investigating new technologies.
  • Skill with manufacturing of products following SOPs, batch records and working within a cGMP regulated environment.
  • Ability to observe technical issues and troubleshooting of process and equipment issues.
  • Ability to operate complex systems and equipment and optimizes their use in manufacturing in accordance with defined goals.
  • Knowledge of specific product-related operations in purification.
  • Skill in leading Purification Department in execution of production and related activities.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meet strategic goals.
  • Ability to ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
  • Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.

For immediate consideration apply today!

Questions? Please reach out to Dustin at

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