QC/AD specialist

6 days ago

Copenhagen, Copenhagen, Denmark Novo Nordisk Foundation Full time

We are looking for a QC/AD lead to join our team.

Are you passionate about cooperating across organizations and cultures? Do you have an analytical mindset and structured approach? Do you take pride in your great interpersonal skills and collaboration abilities? If so, you might be just the person we are looking for.

The Novo Nordisk Foundation Cellerator is poised to spearhead advancements in the cell therapy ecosystem by establishing and operating a state-of-the-art process development and GMP manufacturing facility. This initiative is integral to fulfilling the Novo Nordisk Foundation's strategic emphasis on regenerative medicine and the mission is to accelerate the progress of cell-based therapies toward clinical trials within Denmark's cell therapy ecosystem and beyond, thereby fostering significant growth in the field of stem cell-based therapies, for the benefit of patients.

The Cellerator will operate as a philanthropic entity dedicated to the development and manufacturing of cell-based therapies, serving both academic institutions and the industry alike.

The Job

You will be given a lot of responsibility from day one. You will be part of an international and purpose-driven working environment with colleagues of diverse backgrounds and perspectives.

Your key tasks will include:

  • Subject matter expert for analytical and quality control strategy and method development/implementation
  • Provide analytical guidance and expertise on assay development for quality control during development, manufacture, and release of cell therapy products
  • Accountable for design and equipment for QC and analytical development laboratories
  • Accountable for development of standard operating procedures, study plans, drug substance/drug product specifications, protocols, and method development reports within assay development and quality control
  • Support transfer of analytical test methods (into/out of Cellerator and from development laboratories to GMP performance internally in Cellerator)
  • Accountable for securing oversight of collaborators and vendors within assay development and QC
  • Maintain knowledge of current scientific principles and theories and translate these into the most optimal offerings for Cellerator customers
  • Train other personnel within assay development and QC
  • Management of QC team once the organizational ramp up will be completed
  • Ensure regulatory compliance
About You

Due to the novel nature of the Cellerator, curiosity outside of one's own area is highly valued. You pride yourself on your analytical mindset and structured approach to your tasks. Your former colleagues still talk about your excellent stakeholder management skills, and they miss working with you due to your ability to create both results and good relationships with the people around you. You hold an MSc or PhD in the field of cell therapy, stem cell biology, stem cell engineering or closely related ATMP field.

We also imagine that you have:

  • 5+ years of experience within assay development and quality control
  • 5+ years of experience working in Good Manufacturing Practice (GMP)
  • Vast experience with assay development, method qualification and QC implementation/performance for cell therapy
  • Experience with relevant technologies with emphasis on flow cytometry, functional assays, cell-based assays, Next generation sequencing, ddPCR and other relevant molecular biology technologies
  • Experience with microbiological analyses (sterility, mycoplasma, virus contamination)
  • Ability to analyse and interpret complex data
  • Knowledge related to laboratory information system (LIMS) and electronic lab notebook (ELN)
  • Experience with cell therapy in a CMC or manufacturing setting
  • Experience in team management is considered a bonus but not required

You thrive in a changing and dynamic work environment, and in a job that requires you to take initiatives and think out of the box when challenges occur. You have strong collaborative skills and ability to build good relationships with the people around you.

Next step

If you have any questions regarding the position, please contact CBDO, Novo Nordisk Foundation Cellerator Bo Wiinberg, +45 22288291.

To apply, please send your CV and a short cover letter by clicking the "Apply now" button no later than 10 January 2025.

Working at the Novo Nordisk Foundation

We offer a committed and professional workplace in which we emphasize ensuring that our colleagues thrive, are challenged, and have opportunities to develop their potential. A career at the Novo Nordisk Foundation, Cellerator gives you the opportunity to work:

  • on important projects that improve people's health and the sustainability of society and the planet
  • with key actors within research and development in Denmark and internationally
  • as part of a dedicated team that is passionate about creating impact.
About The Novo Nordisk Foundation

Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people's health and the sustainability of society and the planet. The Foundation's mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.

In the coming years, the Foundation will broaden its scope and increase its grants for scientific, humanitarian, and social purposes, including solving the climate crisis and developing tomorrow's food production. As a consequence, we are a growing organization, which means new job openings and exciting opportunities for employees to be part of forming the future of the Foundation.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

IT Services and IT Consulting

#J-18808-Ljbffr

  • Senior Scientist

    6 days ago

    Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    We're seeking a skilled expert to support clinical and commercial manufacturing for our Customers worldwide. The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry or other relevant area, with +3 years of work experience in QC or analytical development. Fluency in written and spoken English is required, since English is our company...

  • Validation SME in QC Chemistry

    22 hours ago

    Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    We are a collaborative and supportive team, working together to achieve our goals. Our team in QC Chemistry is no exception, and we are seeking an experienced Validation SME in QC Chemistry to join us.As a key member of our department, you will be responsible for method validations, troubleshooting and supporting analytical quality control (QC) activities in...

  • Scientist, QC Chemistry

    10 hours ago

    Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    Scientist, QC Chemistry (temporary) Apply locations Copenhagen, Denmark time type Full time posted on Posted Yesterday job requisition id JR101392 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...

  • QC Analytical Method Specialist

    6 days ago

    Copenhagen, Copenhagen, Denmark AGC Inc Full time

    Job ResponsibilitiesAs a 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. You will support your team colleagues in varying degree of complexity.Your responsibilities will include...

  • Search Ads Specialist til Google Ads og Meta-platforme

    7 days ago

    Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full time

    Karriere hos CleverClever er en dynamisk virksomhed, der leverer innovation og teknologi til markedet. Vores mission er at forme fremtidens e-mobilitet og gøre det nemt for mennesker at køre elbiler. Vi søger en Search Ads Specialist, der kan bidrage til at opnå dette formål. Som en del af vores team vil du være ansvarlig for at optimere og justere...

  • QA / QC Specialist

    10 hours ago

    Copenhagen, Copenhagen, Denmark Eupry Full time

    Eupry Copenhagen, Capital Region of Denmark, Denmark Eupry is a leader in temperature monitoring solutions for GxP industries, ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) requirements. We are seeking a dedicated and detail-oriented QA / QC Specialist to join our team and...

  • Google Ads Expert

    4 days ago

    Copenhagen, Copenhagen, Denmark Growbix Full time

    Hos Growbix søger vi en Paid Search Specialist, der har lyst til at være en central del af et tæt og ambitiøst team.Vi søger efter en person, der kan udvikle taktikker og strategier på Google Ads for vores e-commerce-kunder.Opgaver:Rådgivning af kunder baseret på resultater.Udvikling af vores Google Ads-produkt og holde dig opdateret på den nyeste...

  • QC Chemistry Specialist

    2 hours ago

    Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    About the RoleWe are 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. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in multiple...

  • Scientist & Validation SME, QC Chemistry (18 months maternity cover)

    1 day ago

    Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    Scientist & Validation SME, QC Chemistry (18 months maternity cover) Scientist & Validation SME, QC Chemistry (18 months maternity cover) 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...

  • Senior Validation Specialist

    1 day ago

    Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    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...

  • Specialist i Search Ads og Paid Meta

    7 days ago

    Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full time

    JobbeskrivelseVi søger en Search Ads Specialist, der kan hjælpe os med at opbygge vores digitale kampagner på Google Ads og Meta-platforme. Som Databehandler vil du være ansvarlig for at optimere og justere budstrategier, målgrupper og kreativer for at maksimere ROI.Opgaver:Opsætte og eksekvere kampagner på Google Ads og Meta-platforme, herunder valg...

  • Technical Integration and Ad Optimization Expert

    5 days ago

    Copenhagen, Copenhagen, Denmark Better Collective Full time

    Job RoleWe are seeking a highly skilled and motivated Senior Programmatic Integration Specialist to drive our programmatic revenue growth in the esports sector.The ideal candidate will have a strong background in programmatic advertising and hands-on experience with technical integrations, SSPs, and placement IDs.ResponsibilitiesDevelop and execute...

  • Scientific Method Specialist

    2 hours ago

    Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    We are looking for a talented Scientific Method Specialist to join our team at Novo Nordisk A/S. In this role, you will be responsible for supporting chemical analysis of injectable drug products, both internally in the department and globally in QC laboratories and Contract Manufacturing Organisations (CMOs).You will ensure that our analytical methods are...

  • Analytical Specialist

    10 hours ago

    Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Are you ready for a role as Analytical Specialist within analytical methods used for testing of peptide/protein-based injectable drug products in Novo Nordisk? Are you eager to use your solid experience and competencies within analytical testing techniques such as HPLC, UHPLC, AAS, Raman, ICP and Container Closure Integrity testing to guide and support your...

  • Senior QC Scientist

    7 days ago

    Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

    Senior Quality Control Scientist, QC CMC Biologics Do you want to join our international CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Senior Quality Control Scientist Your new role – why is this a great opportunity? ...

  • Data Centre Mechanical Commissioning Specialist

    6 hours ago

    Copenhagen, Copenhagen, Denmark QCS Staffing Full time

    Company OverviewQCS Staffing is a global specialist in commissioning mission critical projects across all stages of a Data Centre build.We are currently working on an exciting project based in Copenhagen, which involves the construction of a large hyperscale Data Centre facility for a leading multinational corporation and technology company.

  • Specialist i Search Ads og Paid Meta

    7 days ago

    Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full time

    Clever er fyldt med god energi. Vi er optimister. Vi tror på en lysere, mere bæredygtig fremtid og på det gode i mennesker. Vi tror på, at vi sammen kan skabe en mærkbar forskel – ikke bare i dag, men i mange år frem. Derfor søger vi lige nu en barselsvikar, der skal arbejde med optimering af digitale kampagner og tage ansvar for at drive vores...

  • Biotechnology Specialist

    6 days ago

    Copenhagen, Copenhagen, Denmark Novo Nordisk Foundation Full time

    The Novo Nordisk Foundation Cellerator is seeking a seasoned analytical and quality control professional to spearhead the development of cell-based therapies. As a Biotechnology Specialist, you will play a crucial role in designing and implementing analytical strategies, providing expertise on assay development, and ensuring regulatory compliance.With a...

  • Global HR Services Specialist

    2 hours ago

    Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full time

    Key ResponsibilitiesBuild strong partnerships across the organisation to deliver exceptional HR service to our people managers and employeesSupport people managers across all stages of our employees' life cycle, with a particular focus on recruitment, onboarding, and exitingAccountable for the roll out of the annual performance management process (PDP) and...

  • Senior Bioassay Specialist

    1 day ago

    Copenhagen, Copenhagen, Denmark AGC Inc Full time

    Senior Bioassay SpecialistWe are seeking an experienced Senior Bioassay Specialist to join our team in QC General Analytics. The successful candidate will have a strong background in bioanalytical sciences and experience in method validations, regulatory compliance, and quality assurance.The ideal candidate will be responsible for ensuring the accuracy and...