Join a dynamic and international company where everyone is responsible for delivering right on time as one team!
The Position
By joining the QC Raw Material team, you will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late stage projects. As part of daily release flow, you will be responsible for test planning of incoming raw materials, keeping Raw material specifications in compliance, assessing Supplier Change Notifications, as well as providing scientific solutions to contract labs.
The Department
QC Raw Materials is part of the QC organization, which consists of five departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Equipment and Facility and QC Support. QC 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 through phase III and commercial. We are also actively involved in the constant development and improvement of the work environment.
We are looking for a new scientist to join our QC Raw Materials team, which consists of ten skilled colleagues, represented by scientists, technicians, and a Manager.
Key responsibilities
- Author and review raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications
- Deliverance of scientifically sound and cGMP compliant raw material documents and analytical results.
- Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports
- Oversight of sampling, as well internal as outsourced testing.
The Profile
The ideal candidate holds an MSc or PhD degree in Chemistry, Pharmaceutical Sciences or other relevant area and preferably with work experience within quality control or quality assurance. In addition, we expect you to bring some of the following experience and characteristics
- Profound writing and reviewing skills of cGMP documents: raw material specifications, test methods, general procedures
- Experience setting specifications for compendial and non-compendial raw materials
- Indebt understanding of US and European pharmacopoeias
- Experience handling change controls, deviations and CAPAs
- You are an experienced multi-tasker and you enjoy working in a high pace and be challenged in a busy business
- You are a team player combined with the ability and desire to work independently
AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English
AGC Biologics
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. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own.
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 them, and conduct interviews with qualified candidates. When the right candidate is found, the add will close.
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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.
