*Mammalian downstream MFG Scientist

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Do you want to work with protein purification steps in a large scale manufacturing process? 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. The team is responsible for the preparation and process upscaling, manufacturing support, and implementation of new processes, technologies and systems used in GMP operations.

Right now, you have the opportunity to join the Downstream Mammalian Manufacturing team as a Scientist. This position requires technical problem-solving, process understanding and inter-departmental collaboration.

RESPONSIBILITIES:

  • Participate in the project team meetings, decisions, and creation of milestones representing Mammalian Manufacturing.

  • Prepare and present data associated with manufacturing processes to internal and external stakeholders.
  • Provide technical/process support to Manufacturing technicians and other departments associated with GMP operations.
  • Handle deviations, investigations, and process related quality events.
  • Provide input for troubleshooting of processes on the manufacturing floor and during post-operational investigations
  • Perform review and trending of manufacturing campaign data.

  • Present daily manufacturing update, as well as end of campaign status updates.
  • Generate and maintain documents related to GMP Manufacturing, product impact assessments, and campaign summary reports.
  • Serve as the process Subject Matter Expert during audits and regulatory inspections.


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 downstream/ protein purification 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.

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

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.


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 22.8.2022, men kan have været deaktiveret og genaktiveret igen.

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