Associate Principal Scientist, Quality Assurance

4 days ago

Gladsaxe, Gladsaxe Municipality, 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 Assurance of Material Management.
QA for Material Management is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, many with several years of experience within quality assurance.

This QA team is responsible for support of Supply Chain Management and QC in the areas for deviations, CAPA, change management, complaints, GMP documentation etc. in relation to material management. We also have oversight of the respective areas and assist with internal and external audits and regulatory inspections.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that QC and manufacturing are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.

The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations department is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

Tasks and Responsibilities

As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment.

Your main responsibility will be to support Supply chain, Process Transfer and QC for late stage and commercial products, which includes:

  • Close collaboration with internal stakeholders
  • Change control, deviation handling and CAPAs
  • Review and approval of material specifications
  • Release of raw materials and disposables

We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP.

Your Profile

You have 3+ years of experience with Quality Assurance and/or material management. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology, chemistry or similar.

You have experience within the following areas:

  • Proven experience from QA and/or Material Management
  • Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks
  • QA oversight and guidance of staff
  • Experience with contract manufacturing and business understanding
  • Deviation handling including root cause investigations
  • Review and evaluation of cGMP documentation

It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.

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 in order 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.

Contact

Please send all applications via our career site. We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible. The job ad will close once we have found the right candidate.

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 to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

Location: Copenhagen Site

#J-18808-Ljbffr

  • Senior Scientist, Quality Control Specialist

    1 day ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewThe QC Raw Material team at AGC Biologics is seeking a highly skilled Senior/Principal Scientist to support the implementation of new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.Main ResponsibilitiesDevelop and review raw material specifications based on...

  • Quality Assurance Specialist

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About AGC BiologicsAGC Biologics is a global Contract Development Manufacturing Organization (CDMO) providing comprehensive biologics manufacturing services. Our team tailors each client's needs for turnkey manufacturing or sophisticated analytical, formulation, and stability services.We have facilities in Europe, Japan, Italy, and the USA, enabling us to...

  • Senior/Principal Scientist, Quality Control

    1 day ago

    Gladsaxe, Gladsaxe Municipality, 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...

  • Principal Research Chemist, Raw Materials

    21 hours ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the JobWe are looking for an experienced Principal Research Chemist to join our QC Raw Material team at AGC Biologics. In this role, you will be key in implementing new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.Key ResponsibilitiesRaw material specification...

  • Quality Assurance Specialist

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job Overview">We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.This role is part of our development...

  • Quality Assurance Project Coordinator

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Quality Assurance Project Coordinator">We are seeking an experienced Quality Assurance Project Coordinator to join our team at Novo Nordisk A/S. In this role, you will be responsible for coordinating and managing various aspects of our quality assurance processes.">Key Responsibilities">Coordinating with cross-functional teams to ensure compliance and...

  • Quality Assurance Expert

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleAt Novo Nordisk A/S, we are seeking a skilled and motivated Quality Assurance Expert to join our team. In this role, you will play a crucial part in ensuring patient safety by delivering high-quality standards for our products and production processes.The PositionAs an Aseptic Manufacturing Specialist, your primary task will be to review and...

  • Principal GCP Advisor to Drive Digital Quality Excellence

    2 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Principal GCP Advisor to Drive Digital Quality Excellence Category: Quality Location: Søborg, Capital Region of Denmark, DK Looking for a dynamic and challenging role within clinical process management? Do you thrive when using your expertise in GCP, process optimisation skills and quality...

  • Quality Assurance Professional

    2 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are seeking a highly skilled and experienced Quality Assurance (QA) professional to join our team at Novo Nordisk A/S. As a QA specialist, you will play a crucial role in ensuring the quality and safety of our products by delivering high-quality standards for production processes.The position involves reviewing and approving documents...

  • Quality Assurance Professional for API Development

    2 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. As a key member of our team, you will support CMC API Development within the raw material and CMO shipping area.Your Responsibilities:Ensure compliance with regulatory requirements, quality standards, and company policies.Deliver...

  • Compliance and Quality Assurance Lead

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Compliance and Quality Assurance LeadJoin our team as a Compliance and Quality Assurance Lead and play a vital role in ensuring the quality and integrity of our products and services. You will lead the revitalisation of the EMS, follow and update EMS requirements, and communicate them to internal stakeholders.Main Responsibilities:Lead the revitalisation of...

  • Clinical Quality Assurance Specialist

    3 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Company Overview:We are a global healthcare leader with a mission to drive excellence in clinical quality process management.About the Job:We are seeking a highly skilled and experienced Clinical Quality Assurance Specialist to join our team. As a GCP Advisor Specialist, you will be responsible for managing updates to our standard operating procedures (SOPs)...

  • Leaders to Associate Manager Pipeline

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Søborg, Denmark Jobkategori Manufacturing Ansøg nu Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? We have opportunities at all levels making it possible to challenge you and put your skills into play. Joining the Associate Manager Pipeline By applying for the pipeline, you will be...

  • Leaders to Associate Manager Pipeline

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Manufacturing Ansøg nu Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? We have opportunities at all levels making it possible to challenge you and put your skills into play. Joining the Associate Manager Pipeline By applying for the pipeline, you will be...

  • Leaders to Associate Manager Pipeline

    2 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    JobbeskrivelsePlacering Søborg, DenmarkJobkategori ManufacturingAnsøg nuAre you ready to take the next step and pursue a life-changing career at Novo Nordisk? We have opportunities at all levels making it possible to challenge you and put your skills into play.Joining the Associate Manager Pipeline By applying for the pipeline, you will be considered as a...

  • Scientist, Quality Systems

    4 days ago

    Gladsaxe, Gladsaxe Municipality, 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...

  • Biopharmaceuticals Quality Assurance Specialist

    3 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our mission is to bring life-changing therapies for patients worldwide, creating a healthier tomorrow. As a Senior Scientist in our QC Bioassay department, you will be part of our team improving patients' lives by bringing new biopharmaceuticals to market.Job OverviewWe are seeking a highly motivated Senior Scientist to join our QC Bioassay team at AGC...

  • Cell Culture Transfer Scientist

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    The Upstream Process Transfer Scientist position at AGC Biologics offers a unique opportunity to work with a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO).In this role, you will be responsible for the transfer of upstream processes from development to manufacturing, working closely with cross-functional teams and...

  • Senior Scientist, Quality Control

    1 day ago

    Gladsaxe, Gladsaxe Municipality, 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 planning...

  • Biochemistry Scientist

    22 hours ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job SummaryJoin our team as a Senior Scientist, Quality Control and take on the challenge of coordinating and planning analytical QC activities, driving method validation activities, and reviewing release and stability analytical set-ups.About YouA MSc or PhD degree in Biochemistry, Chemistry or other relevant area with at least 3 years of work experience in...