*Scientist for QC Stability
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The Department
QC Stability is part of the QC organization, which consists of six departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Adjuvant, QC Stability and QC Raw Materials. The QC area is responsible for supporting the production of various biopharmaceuticals by controlling raw materials, performing analytical testing, planning and executing stability programs and validating analytical methods according to regulatory guidelines from clinical phase I to phase III and commercial.
QC Stability is responsible for conducting our customer’s stability programs for Drug Substances as well as Drug Products. Furthermore, QC Stability also conducts annual testing of reference materials on request and offers support in freeze-thaw cycle studies of the biopharmaceuticals on request.
We are currently looking for a new colleague to join our QC Stability team, which consists of 8 skilled colleagues with five scientists and three technicians.
Role and Responsibilities
As a Scientist in QC Stability, you will be responsible for establishing the stability protocols for the stability studies and ensuring the timely delivery of interim and final stability reports. In addition, you will as a scientist also have the responsibility of ensuring that we are working according to cGMP compliance in everything we do. Collaboration with the customers and understanding the customer requirements for the stability programs is key and customer support is a central part of the job.
Key responsibilities
- Establish stability protocols and ensure delivery of stability reports to the customers on-time
- Collaboration with colleagues within the department and outside of the department on topics related to stability studies
- Daily support to and scientific sparring with colleagues in relation to the stability programs
- Collaboration with multiple stakeholders including Quality Assurance, Project Management, Process Transfer, Analytical Development and Manufacturing
- Drive compliance documents such as procedure updates, deviations and change requests related to QC activities
- Facilitate and provide training for team members on an as-needed basis
- Ensuring that all tasks are performed in cGMP compliance
The position requires an ambitious employee with a solid knowledge within stability studies. The position offers interaction with several of our customers and we are therefore looking for a scientist with an interest in a high degree of contact with customers and with departments across the organization. The daily challenges will vary a lot, and two days will never be the same.
Qualifications
The ideal candidate holds an MSc or PhD within life sciences and 2+ years of work experience within the pharmaceutical industry preferable working in a quality control area. In addition, we expect you to bring some of the following experience and characteristics:
- Experience with stability programs of drug substances and/or drug products
- Good communication skills, a service-minded attitude and the ability to effectively communicate with others
- Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks
- Knowledge of cGMP systems according to European and US regulatory guidelines is an advantage
- Interest in and the ability to identify areas of improvements to optimize the flow of tasks
- The ability to handle multiple tasks simultaneously in a busy environment
- Experience with LIMS is an advantage
AGC offers
AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.
Application
Submit your application as soon as possible. We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.
For further information regarding the position, please contact Nina Lei, Manager QC Stability, on +45 2269 9363.
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 6.5.2022, men kan have været deaktiveret og genaktiveret igen.
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