Scientist, Quality Control

4 months ago

Gladsaxe Kommune, Denmark AGC Biologics Full time

The Position
You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material.

Your working day is characterized by ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA. Along with your team members, you will work with the Stability aspects of customer projects, including to identify and manage the analytical stability packages needed for the projects.

Your responsibilities involve:

  • Writing and reviewing CR, Deviations, and CAPA documents
  • Writing and reviewing customer-specific stability protocols and reports
  • Engaging with the customers regarding stability topics
  • Overseeing testing at external laboratories
  • Ensuring cGMP compliance with relevant guidelines (EU, FDA)

The Department
You will be part of QC Support in the QC laboratory where you will join a team of highly dedicated scientists and technicians.
QC Support consists of three departments: QC Raw materials, QC Samples & Service, and QC Stability.

The Profile
The ideal candidate holds an MSc in Biochemistry, Pharmaceutical Sciences, or another relevant area and preferably with work experience within quality control or quality assurance.
In addition, we expect you to bring some of the following experience and characteristics:

  • Sound knowledge of stability of DS/DP and cGMP
  • Experience handling change controls, deviations, and CAPAs
  • Knowledgeable of chromatographic and bioassay methods
  • The ability to communicate clearly in English – both in speech and writing
  • Demonstrated experience in driving continuous improvement and/or productivity programs
  • You are a team player combined with the ability and desire to work independently

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.

Location: Copenhagen Site

#J-18808-Ljbffr

  • Senior Scientist, Quality Control Specialist

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Discover a challenging and rewarding opportunity as a Senior Scientist in Quality Control at AGC Biologics. Our purpose is to bring hope to life by enabling life-changing therapies for patients worldwide. With a strong focus on analytical testing and method validation, you will play a key role in supporting the production of new or marketed...

  • Senior Scientist, Quality Control

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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 motivated by leading and participating in coordination and...

  • Senior Scientist, Quality Assurance

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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. Would you like to be a part of AGC Biologics' growing success? We are...

  • Manager, Quality Control

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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. Experienced People Manager for QC Chemistry HPLC Scientists, Quality...

  • Senior/Principal Scientist, Quality Control

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    Join a dynamic and international company where everyone is responsible for delivering right on time as one team! The Position By joining the QC Raw Material team, you will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late stage projects. As part...

  • Senior Quality Control Specialist

    2 months ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our mission at AGC Biologics is to improve patients' lives by bringing new biopharmaceuticals to market. We are seeking a highly motivated and experienced Senior Scientist to lead and participate in the coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers worldwide.The DepartmentQC...

  • Associate Principal Scientist, Quality Assurance

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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. AGC Biologics is looking for an experienced QA scientist to assist with...

  • Quality Control Specialist for Raw Materials

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About AGC BiologicsWe strive to bring hope to life by enabling life-changing therapies for patients worldwide, creating a healthier and happier tomorrow.Our mission is to collaborate closely with our customers to improve patients' lives by introducing new biopharmaceuticals to the market.The PositionYou will be part of the QC Raw Materials Team within QC...

  • QC Bioassay Senior Scientist

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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 a fast-growing international CDMO...

  • Biologics Manufacturing Scientist

    2 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    AGC Biologics A/S is a leading global Contract Development and Manufacturing Organization (CDMO) dedicated to bringing life-changing therapies to patients worldwide. Our mission is to support the development of innovative biopharmaceuticals by providing cutting-edge manufacturing solutions.The position of Senior Scientist is available in our QC Bioassay...

  • Scientist, Quality Systems

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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 experienced in GMP training? Our QMS & Training team in Quality...

  • Senior Stability Scientist

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionWe are seeking a highly skilled Senior Stability Scientist to join our Quality Control team at AGC Biologics in Copenhagen.About the RoleThis is a senior-level position that requires a strong background in stability studies, quality control, and analytical techniques. The successful candidate will work closely with cross-functional teams to...

  • Biological Medicines Scientist

    2 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Unlock a Career in BiopharmaceuticalsAGC Biologics is seeking an experienced Biological Medicines Scientist to join our dynamic team. As a Senior Scientist, you will be responsible for ensuring the timely release and stability testing of biopharmaceutical products.About the RoleReview and approval of analytical results from various bioassay methods,...

  • Scientist, QA Manufacturing Support

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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. The QA Manufacturing Support Scientist is responsible for quality...

  • Senior Scientist

    2 months ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Delivering Hope Through Biopharmaceutical TestingAbout the Role:We are seeking a highly skilled Senior Scientist to join our QC Bioassay team at AGC Biologics. As a key member of our team, you will be responsible for ensuring the timely release and stability testing of biopharmaceutical products for our customers. This involves reviewing and approving...

  • Principle Quality Assurance Specialist

    2 months ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job SummaryAGC Biologics is seeking an experienced QA Scientist to join our team in Copenhagen. The successful candidate will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.Key ResponsibilitiesClose collaboration with internal stakeholdersChange control, deviation handling, and CAPAsReview and...

  • Research and Development Quality Control Expert

    3 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionThis is a dynamic role that involves implementing new raw materials for phase I/II projects, planning the Raw Material Qualification and Release Testing program, and ensuring compliance with regulatory guidelines.ResponsibilitiesDevelop and review raw material specifications based on European or US regulatory guidelines.Create scientifically...

  • Quality Assurance Expert: GMP Facilities and Systems Specialist

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About UsAGC Biologics is a leading Contract Development and Manufacturing Organization dedicated to bringing new biopharmaceuticals to market.We strive to improve life quality by delivering dynamic solutions, technologies, and customized services for protein-based therapeutics and cell and gene therapies.Job DescriptionAs a QA Scientist, you will be a vital...

  • Scientist, Manufacturing

    4 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    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 have experience working in a cGMP environment and are you looking...

  • Scientist, Manufacturing Operations Specialist

    3 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Unlock Career Growth OpportunitiesWe are seeking a skilled Scientist, Manufacturing Operations Specialist to join our team at AGC Biologics in Copenhagen. This exciting role offers the chance to work with cutting-edge technologies and collaborate with diverse nationalities.About the RoleAs a Scientist, Manufacturing Operations Specialist, you will be...