Equipment Scientist for QC Chemistry, UHPLC, CE-SDS and iCIEF

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Do you thrive in a dynamic environment, in a department with skilled colleagues in an organization where we work as one team?

If yes – you might be our new (UHPLC) equipment scientist in QC Chemistry and be part of a growing global CDMO. QC Chemistry at AGC Biologics A/S is expanding and looking for a scientist to purchase, and qualify UHPLC/Chromatographic equipment for our expanding laboratory.

The Job and the department

AGC is growing - we are building a new facility next to our existing facility in Søborg. To support the expansion of the laboratory part, we are looking for a dedicated scientist to support QC chemistry with all tasks related to procurement and qualification of new equipment intended for GMP use in our new laboratory. At AGC Biologics A/S (AGC), we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing.

Since we are a contract manufacturing organization, a high level of service to our clients is in focus. QC Chemistry is one of five departments in the QC area, where we are responsible for supporting the production of new biopharmaceuticals by performing analytical testing of samples from the production and stability programs and validating various analytical procedures according to ICH guidelines from clinical phase I/II to phase III and commercial.

QC Chemistry performs analyzes for manufacturing and stability studies of the API and validation of analytical methods for clinical phase I/II and III. Within this broad working area and with various biopharmaceuticals, the QC area have a close collaboration with all departments across the organization.

The Role and Responsibilities:

As equipment scientist in QC Chemistry, you will be responsible:

  • You will be ensuring that new analytical equipment for our new facility is purchased and qualified in due time to allow expansion of our analytical capacity.
  • You will be authoring URSs, VPLs and VRPs.
  • You are familiar with and understand the context of URS, IQ, OQ, and PQ.
  • Your primary scope is procurement and qualification of HPLCs, CE-SDS and iCIEF.
  • You will also be responsible in procurement (and qualification) of other types of equipment to support the day to day operations of the laboratory.

The position requires hands-on experience with UHPLC maintenance and repair. All work in the department is performed under cGMP and you will be responsible for finalizing service reports and enter work performed in the equipment database.

You’re are:

The ideal candidate holds an MSc or PhD degree in Biochemistry, Chemistry or relevant area and has minimum 5 years of work experience in analytical development or quality control. In addition, we expect you to bring knowledge on equipment qualification from the pharmaceutical industry.

In addition, we expect you to have:

  • (Technical) experience with (U)HPLC, iCIEF and/or CE-SDS equipment qualification and maintenance
  • Experience with working in cGMP settings according to European and US regulatory guidelines
  • Technical experience in protein analytics testing and protein biochemistry
  • Experience in writing of Change Controls, URS, IQ/OQ documents and SOP´s related to analytical equipment is an advantage
  • You are able to prioritize your own tasks in a dynamic environment
  • You are a team player, but work independently
  • Good communication and interpersonal skills
  • Ability to interact positively within a team and in close collaboration with other working areas when needed

Applicants with experience in HPLC, iCIEF and/or CE-SDS analysis will be preferred.

It is important to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality.

Furthermore, you thrive in a challenging and dynamic environment and enjoy a rapid pace of work. You bring a positive, can-do attitude and a good sense of humor.

AGC offers

AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.

Application
Submit your application as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on ourLinkedIn 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 3.2.2022, 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.
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