Lead Manufacturing Associate (Downstream)
Location: 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.
- 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.
- 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.
- 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.