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Are you looking for an exciting job in an expanding international company producing new biological medicines? Do you thrive in a dynamic environment, in a department with skilled colleagues in an organization where we work as one team?
Then, we have the ideal opportunity for you since Quality Control at AGC Biologics is looking for an experienced and quality-minded Scientist for our newly established QC Equipment department.
About the organization
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 development organization, a high level of service to our clients is in focus.
The QC organization consists of 160 dedicated colleagues, and 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.
AGC is growing - we are building a new facility next to our existing facility in Søborg. To support the expansion of the QC laboratories, we have established a new QC Equipment Department. The department is owner of all equipment in QC and responsible for life cycle management activities such as preparation of URSs, procurement, qualification, maintenance, (re)qualification/calibration, and decommissioning. All activities are performed in compliance with cGMP.
Tasks and Responsibilities
As instrument scientist in QC Equipment, you will be responsible for ensuring that analytical instruments for our new facility is purchased and qualified in due time to allow expansion of our analytical capacity. This means that you will be authoring URSs, and associated qualification documentation. Primary scope is procurement and qualification of analytical instruments related to our various analytical methods; this includes HPLCs, CEs, NIR, ELISA readers, SoloVPE, qPCR instruments etc. Furthermore, you will also be responsible for procurement and qualification of other types of equipment like climate chambers, pipettes, balances etc.
The position requires hands-on experience with instrument maintenance. 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.
Qualifications
The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area and has minimum 5 years of work experience from a similar position. We expect you to bring knowledge on equipment qualification from the pharmaceutical industry.
In addition, we expect you to have:
- (Technical) experience with life cycle management of analytical equipment such as HPLC, iCIEF, CE-SDS, ELISA readers, SoloVPE, and qPCR instruments
- Experience with working in cGMP settings according to European and US regulatory guidelines
- Experience in writing Change Controls, URS, IQ/OQ documents and SOP´s related to analytical equipment
- Capacity to prioritize your own tasks in a dynamic environment
- Good communication and interpersonal skills
- Ability to interact positively within a team and in close collaboration with other working areas when needed
- Experience with regulatory inspections
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.
Application
For further information regarding the position, please contact Director Palle Rasmussen, QC Planning and Systems, at [email protected]. We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the add will close.
AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of manufacturing tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent 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.
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 7.8.2023, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
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