*Scientist for QC Bioassay with flair for Compliance

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Are you looking for a unique job in a fast growing international CDMO organization producing new biological medicines? Are you structured, have flair of writing compliance documents and interested in improving our way of working? Then look no further, but come and join us.

In QC Bioassay we are looking for a Scientist with special interest in and flair for writing compliance documents, such as deviations and CAPAs. You will also be involved in method troubleshooting as well as improvement initiatives. All with the purpose to ensure timely QC deliverables to customers from around the globe. You will join a great team of 12 dedicated scientists and report to the Manager of the QC Bioassay Scientist team.

About the department

QC Bioassay is part of the Copenhagen based Quality Control organization, which consists of around 160 dedicated and skilled colleagues divided into five departments (Bioassay, Chemistry, Microbiology, Support and Equipment & Planning). Together as one department, we use our technical expertise when working side by side with customers, to provide innovative solutions to secure timely delivery of reliable and compliant products for patients.

In QC Bioassay, we are a group of dedicated scientists and technicians divided into 4 teams, including the Bioassay Scientist team. We perform a broad range of analytical methods (e.g. ELISA’s, Octet-based methods, SDS-PAGE and pharmacopeia methods). The department is responsible for diverse tasks such as method validation, batch release and stability testing of Drug Substance and Drug Products, as well as coordination and planning of analytical activities and method troubleshooting; All to support our customers.

Role and Responsibilities

In the vacant scientist position you primary responsibilities will be focused on compliance tasks. You are expected to take the ownership of deviations and CAPAs ensuring a high level of quality and completion on time according to our lead times. You will also be involved in troubleshooting of analytical methods and OOS investigations, as well as improvement projects to work even smart´er. All activities are related to Bioassay methods.

Your key responsibilities:

  • Ensure timely completion of deviations, and CAPAs related to QC Bioassay activities
  • Responsible for Initial Laboratory Investigations, including OOS investigations
  • Participate in troubleshooting of analytical methods
  • Participate in regulatory inspections and customer audits
  • Involved in continuous improvement processes
  • Collaborate with multiple stakeholders both within QC as well as cross-functional departments including Analytical Development, Project Managers and QA.
  • Ensure all tasks performed in cGMP compliance

Since we are continuously supporting the manufacturing production, the scientist will might be included in our on-call team responsible for support on review and approval of results outside normal working hours.

Qualifications

The ideal candidate holds a master degree within life sciences and work experience within the pharmaceutical industry preferable from Quality Control. Moreover, you need to be able to obtain new knowledge quickly

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

  • Experience with bioassay methods
  • A strong analytical mindset and troubleshooting skills
  • Hands-on experience with handling deviations and CAPA’s
  • Structures and detailed oriented but also demonstrate a pragmatic can-do-attitude
  • Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
  • Experience working in a GMP environment and knowledge of relevant guidelines

Application
For further information regarding the position, please contact Manager Ann-Louise Theis Littau, at +45 2760 2163. We treat the applications as we receive then, and conduct interviews with qualified candidates. 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 12.5.2023, 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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