*Manager in QC Bioassay, Scientist team
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About the department
Bioassay is part of the Quality Control (QC) organization which consists of 160 dedicated colleagues in five departments: Bioassay, Chemistry, Microbiology, Stability and Raw Materials. We are working in an international and customer oriented way to secure fast and reliable manufacturing of medicines to our customers.
In QC Bioassay we are in total 59 employees, both scientists and technicians, divided into five groups. The Bioassay department performs a broad range of bioanalytical methods as well as cell-based potency assay. The department is responsible for analytical method validations for early and late stage/commercial products, release testing of IPC and drug substance/drug product as well as supporting stability programs.
Role and Responsibilities
As Manager of QC Bioassay Scientist group you will be managing as team of 11 dedicated scientists. The group is responsible for review and approval of analytical results as well as troubleshooting of methods where needed, validation of methods, and owner of compliance documents. All activities are performed in compliance with cGMP.
The manager will be part of the QC Bioassay Management team where support and collaboration is a natural part of the workday. Moreover, the manager will work closely together with other departments within QC as well across the organization.
Your primary tasks will be:
- People management, including performance and development of direct reports
- Delivery of results according to KPIs
- Ensure all activities are in compliance with cGMP
- Provide scientific input and guidance
- Lead continuous improvement projects
- Support regulatory inspections and customer audits
Qualifications
The ideal candidate holds a master degree within life sciences and work experience within the pharmaceutical industry from an analytical development or Quality Control department.
In addition, we expect you to bring the following experience and characteristics:
- 3+ years of experience as manager from similar position
- Demonstrated talent to motivate a team, ensure a good working environment and at the same time deliver high-quality results
- Knowledge within Bioanalytical methods
- Experience working in a GMP environment and knowledge of relevant guidelines
- Has a quality-minded and structured mindset
- Good communication skills and a service-minded attitude
- Able to quickly obtain the overview of multiple tasks in challenged situations, can prioritize and make quick and qualified decisions
Application
For further information regarding the position, please contact Director Henriette S. Nielsen, QC Bioassay, at +45 2294 3092. We treat the applications as we receive then, 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 in order 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.
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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 19.9.2022, men kan have været deaktiveret og genaktiveret igen.
- Forsker
- København
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