*Scientist for Manufacturing Support

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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 a Scientist in one of the Commercial teams. This position requires high level process and compliance understanding as well as inter-departmental collaboration.

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

  • Responsible for/Consulted during MPR creation on process steps to align production flow and GDocP requirements

After batch execution

  • 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

  • Responsible for capturing learnings and align with MPR template owner to continuously improve MPR template
  • Responsible for sharing knowledge across project groups

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, Pharmacy, Biochemistry or Protein Science-related field
  • Experience in preferably in commercial/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.

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 14.11.2023, 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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