Lead Manufacturing Associate (Upstream) - Abzena

Lead Manufacturing Associate (Upstream)

Location: San Diego, CA
Area: Manufacturing

Typical Duties Include

  • Perform work in a cGMP manufacturing environment.
  • Operate in a Class 10,000 and Class 100,000 rooms.
  • Perform cell vial thaw and flask expansion inside a Bio-Safety Cabinet (BSC) as well as generating Cell Banks for clients.
  • Operate and maintain equipment designed for single-use technology as it relates to cell culture such as the GE RTP WAVE 25 and Sartorius STR Systems (50 L to 2000 L).
  • Conduct activities in support of production schedules as directed by senior staff.
  • Determine necessary supplies, know how/where to obtain and stock supplies, when needed.
  • Prepare media supplementation and salt solutions for cell culture production.
  • Maintain GMP records to comply with regulatory requirements and assist with in-process testing.
  • Work is performed independently.
  • Trains all operators on activities prior to GMP execution.
  • Write, revise and approve SOPs, master batch records, specifications, and other applicable cGMP documentation for Manufacturing.
  • Support and direct floor operations for multiple projects simultaneously.
  • Initiate deviations, assess product quality impact, propose and execute Corrective and Preventative Actions (CAPA).
  • Perform manufacturing and process development activities for projects and products in collaboration with others.
  • Provide training to new personnel for Upstream technical processes and equipment.
  • Represent departmental activities as needed, including project teams, training, and evaluation of new technologies.
  • May cross-train on various tasks including Downstream cGMP manufacturing and PD processes as needed to support overall success of the Biologics group.
  • Monitor processes and results to ensure project success.
  • Propose implementation of production procedures to optimize manufacturing processes. Monitor processes and results, and suggest methods to ensure process success.
  • Review completed batch records daily for GMP compliance and completeness.

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 to attend professional conferences, train on new technologies or travel between GMP facilities.
    • Work requires occasional days of more than the standard eight-hour shift, and weekend duty.

 

Qualifications/Skills Required:

  • BA/BS degree that included laboratory work in a chemistry, biology, chemical engineering or related field.
  • Minimum 5 to 10 years of experience in a GMP pharmaceutical or biotech environment.
  • Knowledge and skill with aseptic handling required, including BSC operations to maintain the integrity of open cell culture operations.
  • Expert knowledge of mammalian cell culture processes.
  • Knowledge and understanding of cGMPs and how they apply to duties and responsibilities.
  • Skill using single-use technologies, including tube welding, tube sealing, and disposable systems.
  • Ability to follow detailed instructions and to maintain accurate records.
  • Ability to communicate and delegate skills to effectively coordinate floor operations with staff.
  • Organizational skills to prepare team for operating multiple projects.
  • Ability to successfully multitask, when required.
  • Ability to troubleshoot cell culture operations, preferred.
  • Ability to safely operate production equipment in accordance with established practices.
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