Senior/Principal Scientist, Quality Control

2 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 of daily release flow, you will be responsible for test planning of incoming raw materials, keeping Raw material specifications in compliance, assessing Supplier Change Notifications, as well as providing scientific solutions to contract labs.

Key responsibilities

  • Author and review raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications
  • Deliverance of scientifically sound and cGMP compliant raw material documents and analytical results.
  • Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports
  • Oversight of sampling, as well internal as outsourced testing.

The Profile
The ideal candidate holds an MSc or PhD degree in Chemistry, Pharmaceutical Sciences or other 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:

  • Profound writing and reviewing skills of cGMP documents: raw material specifications, test methods, general procedures
  • Experience setting specifications for compendial and non-compendial raw materials
  • In depth understanding of US and European pharmacopoeias
  • Experience handling change controls, deviations and CAPAs including root cause investigation, and Laboratory Investigations
  • You are an experienced multi-tasker and you enjoy working in a high pace and being challenged in a busy business
  • You are a team player combined with the ability and desire to work independently
  • Experience with contract manufacturing and business understanding
  • Experience in representing area in Audits and Inspections

Location: Copenhagen Site

#J-18808-Ljbffr

  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job Title: Senior Scientist, Quality ControlAt AGC Biologics, we are committed to bringing hope to life by enabling life-changing therapies for patients around the globe. We are seeking a highly skilled Senior Scientist to join our Quality Control team, responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job Title: Associate Principal Scientist, Quality AssuranceWe are seeking an experienced Quality Assurance professional to join our team at AGC Biologics. As an Associate Principal Scientist, Quality Assurance, you will play a key role in ensuring the quality of our biologics manufacturing processes and products.Key Responsibilities:Support Supply Chain,...


  • 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...


  • 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...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Unlock Your Potential in a Dynamic and International EnvironmentThe OpportunityAs a key member of our QC Raw Material team, you will play a crucial role in implementing new raw materials to support new phase I/II projects. Your expertise will be essential in planning the Raw Material Qualification and Release Testing program for late-stage projects. You will...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    The RoleYou will be part of the Quality Control team at AGC Biologics, handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your working day will involve ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA.Your responsibilities will include:Writing and...


  • 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...


  • 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...


  • 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...


  • 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...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking an experienced Manager of Quality Control HPLC Scientists to lead a growing team of dedicated professionals in our QC Chemistry department. As the head of this unit, you will be responsible for ensuring the quality and integrity of our analytical testing and method validations, while collaborating closely with our sister unit of...


  • 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...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the Role: We are seeking a highly motivated and experienced QA Scientist to join our team at AGC Biologics. As a key member of our Quality Assurance department, you will play a vital role in ensuring the quality and compliance of our manufacturing processes and facilities.Key Responsibilities: As a QA Scientist, you will be responsible for:Reviewing...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the PositionAs a Quality Control Specialist at AGC Biologics, you will be part of the QC Stability Team, handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material.Collaborating with stakeholders, you will work with the stability aspects of customer projects, identifying and managing analytical stability packages.Key...


  • 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 Scientist

    2 weeks 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...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking an experienced and skilled Quality Control Manager to lead our QC Chemistry team. As a key member of our team, you will be responsible for overseeing the development and implementation of analytical methods, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive business...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance (QA) Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a crucial role in ensuring the quality of our products and processes, adhering to Good Manufacturing Practice (GMP) standards.Key ResponsibilitiesOversee the quality assurance review and...


  • 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...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewWe are seeking a highly experienced Senior Bioassay Team Lead to join our team at AGC Biologics. The ideal candidate will have a strong background in life sciences, excellent leadership skills, and a proven track record of driving team success.About the RoleAs a Senior Bioassay Team Lead, you will be responsible for leading a team of Scientists...