Senior Scientist, QC Bioassay

3 days ago

Copenhagen, Copenhagen, Denmark AGC Inc Full time

Senior Scientist, QC Bioassay - Evening/Night

Senior Scientist, QC Bioassay - Evening/Night

Apply locations Copenhagen, Denmark time type Full time posted on Posted 2 Days Ago job requisition id JR101735

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.

Do you want to be a part of our Quality Control (QC), General Analytics team? If you are an experienced QC Scientist, then come and join us ensuring continuous QC support for the 24/7 operating manufacturing

The QC Department:

The vacant position is placed in QC Bioassay, General Analytics which is one out of five departments in our QC Organization. In QC Bioassay we are in total 48 employees, both scientists and technicians, divided into five groups - Bioassay Scientists, Bioassay Technicians, Bioassay Cell & ELISA, Bioassay Reference and Critical materials, and General Analytics.

We perform a broad range of compendial methods, bioassays, as well as cell-based assays. We are responsible for method validations for early and late-stage products, release testing of clinical and commercial batches (DS and DP) as well as testing of stability study samples. Finally, but not least we are responsible for supporting the 24/7 operating manufacturing of biopharmaceuticals by testing of in-process stop/go samples.

QC General Analytics is organized to support the in-process stop/go testing 'outside normal working hours', i.e. evenings/nights, both on weekdays and weekends. The stop/go support is mainly protein measurements using OD280/SoloVPE but will soon expand to also include HPLC methods. Beside this, the team is responsible for all release and stability testing and method validations of compendial methods such as Osmolality and pH, as well as OD280/SoloVPE methods.

Role & Responsibilities:

As senior Scientist in QC General Analytics you will be joining the team consisting of 3 Scientists and 6 technicians working 'outside normal working hours' covering the period between 16:00 – 06:00, all seven days a week. As we are continuously supporting the manufacturing production, the group of Scientists are included in our on-call plan and weekend shift plan - each Scientist covering no more than a weekend shift every second or third week.

As an experienced Scientist in the team, you will support your team colleagues in varying degree of complexity. You will work somewhat independent, participate in initiatives or projects to deliver to overall department objectives.

Key Tasks:

  • Participate in analytical method validations
  • Participate in operational planning together with your colleagues.
  • Ensure all activities follow cGMP.
  • Support regulatory inspections and customer audits.

Your Profile & Qualifications:

The ideal candidate holds a Master's degree within life sciences and +3 years of work experience within the pharmaceutical industry working in a GMP environment and preferably in QC.

In addition, we expect you to bring some of the following experiences and characteristics:

  • Some experience from working in a GMP environment and knowledge of relevant guidelines
  • Has a quality and structured mindset and preferably experience in writing and reviewing GMP documentation, including CR-cases, CAPAs, and deviations
  • Some experience in preparing and optimizing procedures (SOPs, TEQs, etc.) to ensure continuous compliance with GMP
  • Good communication skills, a service-minded attitude and the ability to effectively communicate with others
  • 'can-do' attitude
  • The ability to handle multiple tasks simultaneously in a busy environment.

Your Application:
We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the add will close. For further information regarding the position, please contact Manager Sandra Madsen, QC Bioassay, at +45 26105244.

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.

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