*Scientist for QC General Analytics

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Are you looking for an exciting job in a fast-growing international CDMO organization producing new biological medicines? Do you enjoy working evening and nights, and do you thrive in a dynamic environment, where you will be involved in multiple different tasks of varying complexity? Then come and join us in our QC General Analytics team, critical for the support of our 24/7 manufacturing facility.

AGC Biologics A/S is a global CDMO, where we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. We are working in an international and customer-oriented way to secure fast and reliable manufacturing of medicines to our customers.

The Department

The vacant position is placed on QC Bioassay which is one out of five departments in our QC Organization. In QC Bioassay we are in total 48 employees, both scientists and technicians, divided into four groups including the QC General Analytics team. We perform a broad range of analytical methods including different pharmacopeia methods. Furthermore, we are responsible for method validations for early and late stage products, release testing of clinical and commercial batches (DS and DP) as well as testing of stability samples. Finally, but not least we are responsible for supporting the 24/7 operating manufacturing of biopharmaceuticals by testing of in-process stop/go samples.

Role and Responsibilities

The QC General Analytics team is working outside normal working hours and covers weekdays as well as weekends. This team is critical for the support of our 24/7 operating manufacturing, by real-time testing of in-process stop/go samples. As Scientist you will join a team of 8 colleagues, both technicians and scientists, and report into the Team Leader of QC General Analytics.

In the vacant position you will be involved in multiple different tasks all related to ensure timely testing of product for our customers. You will be responsible for review and approval of results from a broad range of methods, method validation activities, as well as compliance activities. Furthermore, you will be involved in coordination and execution of analytical activities in QC Bioassay and across the QC area.

Your key responsibilities:

  • Review and approval of analytical results
  • Responsible for method validations according to current ICH guidelines
  • Participate in troubleshooting and scientific support on a broad range of bioassay methods
  • Drive compliance documents related to QC activities
  • Collaboration with multiple stakeholders both within QC and cross-functional departments including Analytical Development, Project Managers, and QA
  • Ensuring all tasks performed in cGMP compliance

Qualifications

The ideal candidate holds a master degree within life sciences and has preferable experience from the pharmaceutical industry preferable from Quality Control or an Analytical Development department.We expect that you thrive working in a dynamic environment and able to keep the overview of multiple simultaneous tasks also when priorities are frequently changing. Moreover, you must be able to work independently and able to take decisions.

In addition, we expect you bring some of the following characteristics and capabilities:

  • Experience with bioassay methods
  • A strong analytical mindset and troubleshooting skills
  • Structures and detailed oriented but also demonstrate a pragmatic can-do-attitude
  • Hands on experience with handling laboratory investigations, deviations and CAPA’s
  • Experience with working in a cGMP setting according to EU and US guidelines
  • Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
  • Fluency in English is a requirement as English is our corporate language

Application
For further information regarding the position, please contact Team Leader Cephas Mwanasaka at +45 2760 2509. We treat the applications as we receive, and conduct interviews with qualified candidates. Therefore, please submit your application as soon as possible. When the right candidates are found, the add will close.

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 19.10.2023, 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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