AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com.

Scientist for QC Chemistry, working within Raw Materials in our Quality Control Department

Join a dynamic and international company where everyone is responsible for delivering right on time as one team!

The Department
The QC department at AGC Biologics consists of three functional groups: QC Bioassay, QC Chemistry, and QC Microbiology. The QC groups are responsible for supporting the production of new biopharmaceuticals by controlling raw materials, performing analytical methods, planning and executing stability programs and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial.
Within this broad working area, many different customers’ projects and with various biopharmaceuticals the QC department differs from traditional QC labs. The position requires an engaged, ambitious employee and advantage with depth knowledge within raw materials for pharmaceutical manufacturing and FT-NIR analysis. QC have a close collaboration with customers, and departments across the organization to gain control of all steps in the manufacturing processes.

Tasks and Responsibilities
The position is within QC Chemistry and you will be responsible for delivering scientifically sound and cGMP compliant raw material documents, ensure timely delivering of raw materials test results. A major part of the job will be creating of raw material specifications , involved in operating the raw material program, including performing raw material risk assessments, creating qualification protocol/reports for compendial and non-compendial raw materials, oversight of sampling and internal and outsourced testing.

You will have contact with customers with diverse backgrounds and cultures; for that reason good communication skills are essential. Cooperation with the customers will at times be very close, and will have consultative character in order to solve customer challenges together.
On a daily basis the tasks also include improvement of laboratory GMP systems according to European and US regulatory guidelines. QC Chemistry is looking for an engaged and ambitious person, willing to go the extra mile.

Key tasks are:

• 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 as internal and outsourced testing.

Your Profile
The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or relevant area and has minimum 3 years of work experience within raw materials and/or analytical development or quality control. In addition we expect you to bring some of the following experience and characteristics:
• Technical experience within raw materials for cGMP production for phase I/II trough commercial licensing raw material testing.
• Experience with FT-NIR analysis of raw materials is an advantage.
• Experience setting specifications for compendial and non-compendial raw materials
• Ability to oversee a raw material program supporting multiple products and processes.
• Write and review cGMP documents (e.g. raw material specifications, test methods, general procedures).
• Review and approve analytical results for cGMP compliance and scientific content.
• 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
• Excellent communication, presentation and interpersonal skills.

AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English.

AGC offers
AGC offers a dynamic workplace with good opportunities to work with a wide and varied range of tasks and challenges. You will be inaugurated in and have experience with the way the various departments in a "Contract Manufacturing Organization" (CMO), collaborate to achieve success. Exciting and challenging assignments will come to you in a steady stream, and you will very largely able to plan your day. AGC offers an informal and humorous working environment that is characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.

For further information regarding the position, please do not hesitate to contact Director QC Chemistry, Iben Schildt Sørensen, telephone +45 2294 2949.
We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than December 21, 2019. We treat the applications as we receive them, and qualified applicants can expect to be interviewed before the deadline.