Principal Scientist/Scientist with background in Chromatography for QC Adjuvant

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Are you looking for a challenging and varied job within QC Adjuvant? Do you thrive in a dynamic environment, in a department with skilled colleagues in an organization where we work as one team? Are you focused on problem solving and have a flair for LEAN? Then we might have just the job for you, a position for an Experienced Scientist in QC Adjuvant is open for a new colleague with chromatographic experience, strong cGMP skills and the ability to thrive in a team.

The Department

QC Adjuvant is part of the QC organization, which consists of six departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Adjuvant, QC Stability and QC Raw Materials. The QC area 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 to phase III and commercial.

QC Adjuvant was established one year ago as a new QC department in our organization as we ensure QC testing of Adjuvant for one of the World’s next Covid-19 vaccines.

We are currently looking for a new colleague to join our QC Adjuvant team, which consists of 11 skilled colleagues with four scientists and seven technicians.

Role and Responsibilities

As an experienced Scientist in QC Adjuvant, you will be responsible for the timely review and approval of analytical results to one of our largest customers within Covid-19 vaccines. In addition to delivering analytical results to the project, you will as a scientist also have the responsibility of ensuring that we are working according to cGMP compliance in everything we do. The collaboration with the customer on delivering the next Covid-19 vaccine to the market is currently in a very exciting phase where we are preparing to go commercial.

Key responsibilities:

  • Take lead on and collaborate with QC Adjuvant scientists on troubleshooting of analytical methods

  • Handling and driving compliance task such as OOS/OOT/OOE, deviations and CAPA:s
  • Daily support to and scientific sparring with our laboratory technicians in relation to the execution of analytical assays, equipment usage, reagent availability and preparation
  • Collaboration with multiple stakeholders including Quality Assurance, Project Management, Process Transfer, Analytical Development and Manufacturing
  • Drive compliance documents such as procedure updates, laboratory investigations, deviations and change requests related to QC activities
  • Facilitate and provide training for team members on an as-needed basis
  • Deliver analytical results to the project on-time
  • Ensuring that all tasks are performed in cGMP compliance

The position requires an ambitious employee with a solid knowledge within chromatographic (HPLC) methods. The position offers interaction with one of our largest customers and is unique in having contact with departments across the organization. The daily challenges will vary a lot, and two days will never be the same.

Qualifications

The ideal candidate holds a PhD/MSc. within life sciences and 6+ years of work experience within the pharmaceutical industry preferable working in a quality control area. In addition, we expect you to bring some of the following experience and characteristics:

  • Extensive experience with chromatographic methods (UPLC/HPLC with various detectors)

  • Experience with Chromeleon software and LIMS

  • Good analytical and troubleshooting skills

  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks

  • Knowledge of cGMP systems according to European and US regulatory guidelines is an advantage

  • Good communication skills, a service-minded attitude and the ability to effectively communicate with others

  • Interest in and the ability to identify areas of improvements to optimize the flow of tasks

  • The ability to handle multiple tasks simultaneously in a busy environment

  • Big interest in problem solving

  • Experience in LEAN


AGC offers
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. 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 then, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.

For further information regarding the position, please contact Stella Brudin, Manager QC Adjuvant, at +45 2760 2473

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 !

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.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 3.2.2022, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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