Scientist & Validation SME, QC Chemistry (18 months maternity cover)

3 days ago

Copenhagen, Copenhagen, Denmark AGC Biologics Full time

Scientist & Validation SME, QC Chemistry (18 months maternity cover)

Scientist & Validation SME, QC Chemistry (18 months maternity cover)

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.

This role is a maternity cover for 1.5 years.

Are you motivated by method validations, troubleshooting and supporting analytical quality control (QC) activities in order to support clinical and commercial manufacturing for our Customers worldwide? Do you thrive in an international environment where teamwork and collaboration are on top of the agenda? Then we might have just the right opportunity for you as 1.5 years maternity cover in QC Chemistry

The QC Chemistry Department:

QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new or marketed 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 has a close collaboration within the QC area and with departments across the organization as well as AGC Biologics external Customers and external vendors.

The QC Scientist Role & Responsibilities:

As (Senior) Scientist and Validation SME 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 driving PhI/II and PhIII/Commercial method validation activities, reviewing release and stability analytical set-ups, supporting lab technicians, authoring SOPs and running Lab Investigations, Deviations/CAPAs and CR cases. Since you will participate in method relevant Customer meetings and provide input for validation plannings, good communication skills are essential together with a general understanding of planning and coordination of activities.

Your Profile:

The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area and has +3 years of work experience in QC or analytical development. Candidates with experience from PhIII Validations will have an added advantage. Fluency in written and spoken English is a requirement, since English is our company language.

You ideally bring some of the following experience:

  • 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 for PhI/II and/or PhIII.
  • 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, solution-oriented approach to the daily work, without compromising quality. You thrive in a dynamic environment and enjoy a rapid pace of work where we all work as one team. Also, you bring a positive, can-do attitude and a good sense of humor.

You ideally bring some of the following characteristics:

  • Excellent communication, presentation, and interpersonal skills.
  • 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 with ability to work independently.

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.

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

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit .

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