Manufacturing Associate (Downstream) - Abzena

Manufacturing Associate (Downstream)

Location: San Diego, CA
Area: Manufacturing

Position Responsibilities:

  • Duties involve use with chromatography, ultrafiltration, normal flow filtration, and single-use technologies.
  • Operates and maintains production equipment with single-use materials as it relates to harvest and protein purification (chromatography columns, depth filtration, cassette-based ultrafiltration equipment, UV monitors, pH/conductivity, viral filtration, skids).
  • Conduct activities in support of production schedules and objectives as directed by senior staff.
  • Obtains and stock supplies as directed.
  • Prepares buffers, packs and tests chromatography columns.
  • Maintains records to comply with regulatory requirements and assist with in-process testing.
  • Writes, reviews, and approves SOPs, master batch records, specifications, and other cGMP documentation.
  • Supports multiple projects simultaneously.
  • Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA).
  • Perform manufacturing and process development activities for projects and products in collaboration with others.
  • Provides training to new personnel in a specific technical process.
  • Represents departmental activities as needed, including project teams, training, and evaluation of new technologies.
  • May cross-train on various tasks including Upstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
  • Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
  • Reviews completed Production, Buffer, and Purification batch records.

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Inventory manufacturing lab supplies and ensure items are properly stocked
  • Maintains records to comply with regulatory requirements and assist with in-process testing.
  • Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena’s business.
  • Travels as needed.

Qualifications/Skills Required:

  • AA/AS or BA/BS degree that included laboratory work in a chemistry, biology, chemical engineering or related field.
  • Basic knowledge of protein purification.
  • Skill with chromatography, ultrafiltration, normal flow filtration, and single-use technologies.
  • Ability to follow detailed instructions and to maintain accurate records and notes.
  • Ability to work effectively in a team environment.
  • Ability to successfully perform multiple tasks, when required.
  • Skills in problem solving and troubleshooting.
  • Ability to safely operate production equipment in accordance with established practices.
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