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Manufacturing Operations Expert

1 week ago

Copenhagen, Copenhagen, Denmark AGC Biologics Full time

About the Job Description

This job description outlines the key responsibilities and requirements for the position of Scientist at AGC Biologics.

The successful candidate will be responsible for ensuring the highest standards of quality in our production processes.

Key Responsibilities:

  • Master Production Record Management: Create, review, and maintain Master Production Records.
  • Production Support: Provide on-call/shopfloor support during critical process steps and facilitate solutions during breakdowns in batch execution.
  • Deviation Management: Accountable for timely deviation closure, including systematic problem-solving during root cause investigations and handling other quality documents.
  • Compliance: Establish and maintain procedures to ensure compliance with cGMP regulations.
  • Customer Interaction: Act as a representative in customer meetings and support audits and inspections.
  • Continuous Improvement: Capture learnings and implement continuous improvements to processes.
  • Training: Responsible for project-specific training of technicians.

Main Areas of Focus

We are looking for scientists to support the following main areas:

  • Microbial Production
  • Mammalian Production
  • Solution Preparation
  • Manufacturing Support
  • Facility & Equipment
  • Material Management

Within these areas in Manufacturing, you will be involved in:

  • Upstream Processing: Cultivation of cells, media preparation, and bioreactor operation.
  • Downstream Processing: Protein purification, filtration, and chromatography.
  • Solution Preparation: Buffer preparation, media and solution mixing, and sterilization.

About You

To succeed in this role, we imagine that you have:

  • A relevant degree in a scientific or technical field.
  • 1+ years of experience in the biopharmaceutical or related industry, preferably in a cGMP environment.
  • Experience with protein purification and chromatography.
  • Strong collaboration and communication skills.
  • Proficiency in English (reading, writing, and speaking).
  • Ability to handle unpredictability and work effectively in a dynamic environment.

Preferred Competencies and Experiences

We would love it if you also had:

  • Masters or Bachelor's Degree in natural or life science-related fields.
  • Knowledge of upstream or/and downstream processes.
  • Experience writing, reviewing, and approving GMP documentation.
  • Experience with operations of single-use technologies and aseptic processing.
  • Experience in clinical/commercial GMP manufacturing.
  • Self-motivated, organized, and proactive.
  • Ability to coordinate multi-departmental tasks and deliverables.
  • Experience working with multiple projects simultaneously.
  • Demonstrated experience leading troubleshooting efforts.
  • Strong communication and presentation skills necessary to interact with internal and external stakeholders.