The Commercial team owns the production process of all commercial products. This includes to support the value streams with an error-free and timely production execution and own batch documentation, review and deviation handling. The team has in depth knowledge of the commercial product specific requirements.

 
RESPONSIBILITIES: 

Prior to batch execution

• Accountable for MPR creation, high level batch initiation process and cleaning procedure for product contact items
• Responsible for reviewing MPI and BOM 
• Responsible for MPR (project specific) training of technicians 

Batch execution

• On call/shopfloor scientist to ensure on the line support during critical process steps
• Responsible for facilitating solutions on how to proceed during break-down during batch execution
• Responsible for participating during ENG batch 

After batch execution

• Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation)

Other 

• Customer meeting representative
• Audits and inspection support
• Responsible for capturing learnings and implement cont. improvements to process
• Knowledge about requirement for commercial products

EDUCATION AND EXPERIENCE: 

The ideal candidate holds an Academic degree within science and have previously been working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences: 

• Master’s Degree in Engineering or Protein Science-related field 
• Experience in upstream operations, preferably in clinical/commercial GMP manufacturing. 
• Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.). 
• Have experience writing, reviewing and approving GMP documentation. 
• Experienced with operations of single-use technologies and aseptic processing. 

• Self-motivated, organized and proactive. 
• Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Development, Engineering, QA, QC, etc.). 
• Experience working with multiple projects simultaneously. 
• Demonstrated experience leading troubleshooting efforts. 
• Strong communication skills necessary to interact with internal and external stakeholders. 

• Strong presentation skills.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among 40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team. 

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.