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Senior Scientist, Quality Control

2 months ago


København, Denmark AGC Inc Full time
Senior Scientist, Quality Control

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you looking for an exciting job in an international and challenging environment? Do you thrive in a dynamic environment, in a department with skilled colleagues in an organization where we work as one team? This is a great opportunity to make the most of your expertise and passion for analytical chemistry.

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 organization, a high level of service to our clients is in focus.

The Department

QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. QC Chemistry have a close collaboration within the QC area and with departments across the organization.

Roles and Responsibilities

As a scientist in QC Chemistry, it is required that you have expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF and CGE-SDS. You will be reviewing release and stability analyzes, supporting lab technicians daily, documenting validation activities of analytical methods for clinical phase I/II and III and authoring SOPs. You will represent QC Chemistry in customer project teams, and good communication skills are essential together with project management skills.

Your Profile

The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or relevant area and has a minimum of 5 years of work experience in analytical development or quality control. In addition, we expect you to bring some of the following experience and characteristics:

  • Working and troubleshooting experience with SE-, IEX- and RP-UHPLC, iCIEF and CGE-SDS analysis.
  • Experience with Chromeleon software and LIMS
  • Technical experience in protein analytics testing and protein biochemistry
  • Experience in validating analytical methods according to ICH guidelines
  • Excellent communication, presentation, and interpersonal skills
  • Interest in and experience in project management acting as QC representative in customer projects
  • You like to share your knowledge and communicate openly and professionally both internally and with external customers
  • You are able to prioritize your own tasks in a dynamic environment
  • You are a team player, but work independently
  • Fluent in written and spoken English
  • Experience with working in cGMP settings according to European and US regulatory guidelines

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.

AGC Offers

AGC offers a dynamic working place with good opportunities of working with a varied array of 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.

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 candidates are found, the ad will close.

AGC Biologics 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).

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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