Biologics - Upstream/Production Manufacturing Manager - Abzena

Biologics – Upstream/Production Manufacturing Manager

Location: San Diego, CA
Area: Manufacturing

Current Responsibilities:

  • Leads, mentors, and trains all manufacturing employees in execution of production activities, serves as a role model and provides career development and direction.
  • Responsible for specific product-related operations in cell culture/fermentation. Functions as a Subject Matter Expert for manufacturing.
  • Responsible for specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to Scientific/Manufacturing senior management.
  • Responsible for all activities involving aseptic technique and maintains production equipment with single-use materials as it relates to cell culture (Stir-Tank bioreactors, Wave bioreactors, incubators, shakers, and cell separation equipment).
  • Provides detailed observations, analyzes data, and interprets results. Communicates these results to others.
  • Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA).
  • Reviews and approves SOPs, master batch records, and other cGMP documentation Prepares technical reports, summaries, protocols, batch records and quantitative analyses as needed.
  • Change owner for implementation or revision of equipment, documentation, and material specifications.
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Supports multiple projects simultaneously.
  • Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
  • 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.
  • Assists coordinating with downstream operations.
  • Provide input and feedback on performance of production associates and lab technicians.
  • Performs other related duties as required.

 

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena 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 business.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena strategic goals.
  • May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
  • Travels as needed to attend professional conferences, train on new technologies, and execute process transfer in support of clients.
  • May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.

 

Qualifications/Skills Required:

  • BA/BS or MA/MS degree that included laboratory work in biology, microbiology, chemical engineering or related field.
  • Minimum five (5) years of experience with MA/MS or minimum eight (8) years with BA/BS as an Upstream/Production Associate, or equivalent, in a GMP environment. Supervisory role experience a must.
  • Knowledge of mammalian cell culture for production of biopharmaceuticals.
  • Skill with aseptic technique, bioreactor operation and single-use technologies following SOPs, batch records and working within a cGMP regulated environment.
  • Demonstrated ability to observe technical issues and directs troubleshooting of process and equipment problems.
  • Ability to organize workload, oversee workload of direct reports, and relevant resource requirements.
  • Skill in leadership duties, to include time management and planning.
  • Ability to successfully perform multiple tasks, when required.
  • Ability to safely operate production equipment in accordance with established practices.
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