*Scientist for Manufacturing Support (temporary)

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Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.

As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be for drugs ranging from development, to clinical and commercial production. Right now, you have the opportunity to join the Manufacturing Product Support department as we have several open positions across the department within upstream, downstream or Review Scientist in one of the teams. This position requires technical problem-solving, process understanding and inter-departmental collaboration. 

These positions are 12 month temporary positions.

The Clinical and Commercial teams own the production process of all clinical and 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 clinical 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 
  • Responsible for/Consulted during MPR creation on process steps to align production flow and GDocP requirements

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)
  • Accountable for timely batch review according to KPI

  • Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation) according to KPI
  • Responsible for enabling timely batch release
  • Responsible for data feedback/status on release process

Other 

  • Customer meeting representative

  • Audits and inspection support
  • Responsible for capturing learnings and implement cont. improvements to process
  • Knowledge about requirement for clinical 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 or downstream 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. 

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


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 24.10.2023, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • København

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