Lead Manufacturing Associate (Downstream) - Abzena

Lead Manufacturing Associate (Downstream)

Location: San Diego, CA
Area: Manufacturing

Position Responsibilities:

  • 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.
  • Leads and mentors all manufacturing staff.
  • 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.

 

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • 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 between GMP facilities, to attend professional conferences, and train on new technologies.

 

Qualifications/Skills Required:

  • BA/BS degree in Biology, Chemistry or a scientific related field.
  • Minimum of five (5) years of experience in a cGMP manufacturing/laboratory environment, with two (2) of those being in a lead role.
  • 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 Abzena’s 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.
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