Scientist, QC Planning

2 months ago


København, Denmark AGC Inc Full time
Scientist, QC Planning & Systems (Maternity replacement)

Locations: Copenhagen, Denmark

Time Type: Full time

Posted on: Posted Yesterday

Job Requisition ID: JR100890

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.

QC Equipment Scientist

Are you looking for an exciting job in an expanding international company producing new biological medicines? Do you thrive in a dynamic environment, in a department with skilled colleagues in an organization where we work as one team?

Then, we have the ideal opportunity for you since Quality Control at AGC Biologics is looking for an experienced and quality-minded Scientist for our QC Equipment department.

We are looking for a Temporary Scientist (end November 30, 2025) to join our QC Equipment team, which consists of 10 skilled colleagues, represented by 5 scientists, 4 technicians, and a manager.

About the organization

At AGC Biologics A/S (AGC), we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. Since we are a contract manufacturing development organization, a high level of service to our clients is in focus.

The QC organization consists of 160 dedicated colleagues, and we are responsible for supporting the production of new biopharmaceuticals by performing analytical testing of samples from the production and stability programs and validating various analytical procedures.

AGC is growing - we are building a new facility next to our existing facility in Søborg. QC equipment is the owner of all equipment in QC and responsible for life cycle management activities such as preparation of URSs, procurement, qualification, maintenance, (re)qualification/calibration, and decommissioning. All activities are performed in compliance with cGMP.

Tasks and Responsibilities
As a scientist in QC Equipment, you will be responsible for ensuring that analytical instruments for our new facility are qualified in due time to allow expansion of our analytical capacity. You will be authoring URSs and associated qualification documentation, and you will be responsible for understanding the context and scope of URS, IQ, OQ, and PQ. The primary scope includes maintenance of equipment in the current facility and qualification of analytical instruments related to our various analytical methods; this includes HPLCs, CEs, ELISA readers, SoloVPE, qPCR instruments, etc. Furthermore, you will also be responsible for procurement and qualification of other types of equipment like water baths, pipettes, balances, etc.
All work in the department is performed under cGMP, and you will be responsible for finalizing service reports and entering work performed in the equipment database.

Qualifications

The ideal candidate holds a MSc degree in Biochemistry, Chemistry, or a relevant area and has work experience from a similar position. We expect you to bring knowledge of equipment qualification from the pharmaceutical industry.

In addition, we expect you to have some of the following experiences and characteristics:

  • (Technical) experience with life cycle management of analytical equipment such as HPLC, iCIEF, CE-SDS, ELISA readers, SoloVPE, and qPCR instruments.
  • Experience working in cGMP settings according to European and US regulatory guidelines.
  • Experience in writing Change Controls, URS, IQ/OQ documents, and SOPs related to analytical equipment.
  • Capacity to prioritize your own tasks in a dynamic environment.
  • Good communication and interpersonal skills.
  • Ability to interact positively within a team and in close collaboration with other working areas when needed.

It is important to have a self-motivating personality with a pragmatic attitude and approach to daily work - without compromising quality. 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 humour.

Application
For further information regarding the position, please contact Manager Johan Bollhorn, QC Equipment, at We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

AGC offers
AGC offers a dynamic working place with good opportunities to work with a varied array of manufacturing tasks and challenges. You will gain insight into and experience with how the various departments throughout a contract manufacturing organization interact to achieve success. Exciting and challenging assignments will constantly come your way, and you will largely be able to plan your daily work yourself. AGC offers an informal working environment, where humour 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.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

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 proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit

Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations, and ordinances.

#J-18808-Ljbffr
  • Senior QC Scientist

    2 months ago


    København, 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? ...


  • København, Denmark AGC Inc Full time

    Scientist, Senior/Principal Scientist, Quality Control Apply Location: Copenhagen, Denmark Time Type: Full time Posted on: Posted 17 Days Ago Job Requisition ID: JR101009 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...


  • København, Denmark AGC Inc Full time

    Senior Scientist, Quality Assurance Locations: Copenhagen, Denmark Time Type: Full time Posted on: Posted 26 Days Ago Time Left to Apply: End Date: November 8, 2024 (3 days left to apply) Job Requisition ID: JR101027 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier...

  • QA/QC Manager

    4 weeks ago


    København, Denmark Blackswansexist Full time

    What if your job was about ensuring the consistent delivery of high-quality products that make a positive impact on the world? Our client has built strong foundations, and now they are looking for someone passionate about maintaining and optimizing our quality standards. If you thrive in a dynamic biotech environment, where no two days are the same, and...


  • København, Denmark AGC Inc Full time

    Quality Control Technician Pipeline, AGC Biologics 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 interested in...


  • København, Denmark Novozymes AS, part of Novonesis Group Full time

    Recovery Scientist, Product and Process Development, Novonesis, Bagsværd Are you ready for a new beginning? We need your talent, knowledge and dedication to better our world with biology. Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century...


  • København, Denmark H. Lundbeck AS Full time

    Do you have a passion for LC-MS and like to work with “state of the art” technologies? Do you thrive with scientific challenges? Then you may be our new colleague. Your new role – why is this a great opportunity? You will be responsible for planning, conducting, and reporting of in vitro and in vivo ADME studies, including metabolite profiling and...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly unique, determined to be...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • København, Denmark Genmab AS Full time

    The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Senior Digital Product Owner, CMC, R&D Digital Products At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change...


  • København, Denmark Københavns Universitet Full time

    DARK Fellowships are postdoc positions for scientists intending to carry out independent research within the areas of interest to DARK. DARK Fellows are invited to work with faculty and junior professors at DARK and will have access to a range of international observing facilities, computing facilities, and an assortment of international collaborations....


  • København, Denmark DIS - CREADIS Engineering Solutions & Consulting Full time

    We are experiencing significant growth and are seeking additional colleagues to focus on QA and validation tasks for a wide range of customers within the life science industry. Together with skilled colleagues, you will take part in the exciting journey! Your Role in Future Projects As an employee at DIS, you will become part of an ambitious environment...

  • Account Director

    2 months ago


    København, Denmark IT Minds Full time

    Jul 18, 2024 Seize the opportunity to become our Account Director, guiding a dedicated team in the thrilling launch of a new loyalty program across 30+ markets. You'll be the strategic force cultivating deeper brand connections, mastering the art of customer retention, and sparking a cycle of constant reactivation. If you're ready to champion a loyalty...


  • København, Denmark Resolve Full time

    Staff Software Engineer at Resolve In the Resolve Core team, we're levelling the playing field for legitimate publishers in the competitive digital market. By providing cutting-edge solutions that maximise data value while ensuring privacy, we empower our partners to thrive! Join our high-impact Resolve Core team and play a pivotal role in defining the...


  • København Huse, Denmark Abbott Laboratories AS Full time

    Job Title: Key Account Manager DenmarkAbbott Laboratories A/S is seeking a highly skilled and experienced Key Account Manager to join our team in Denmark. As a Key Account Manager, you will be responsible for delivering revenue objectives in the Vascular division and strengthening our position in preparation for future launches in Denmark and Norway.Key...


  • København Huse, Denmark Abbott Laboratories AS Full time

    Job OpportunityWe are seeking a highly skilled Key Account Manager to join our Abbott Vascular division in Denmark.As a Key Account Manager, you will be responsible for delivering revenue objectives in Vascular and strengthening our position in preparation for future launches in Denmark and Norway.The role is field-based, with a focus on visiting customers...


  • København, Denmark Københavns Universitet Full time

    Background At present, field phenotyping of complex traits associated with biomass development is a labor-intensive process, which often involves destructive measurements. Researchers and breeders are therefore interested in incorporating the use of automated, non-destructive, high-through-put field phenotyping methods into pre-breeding and breeding...


  • København, Denmark Københavns Universitet (KU) Full time

    We are looking for two highly motivated and dynamic assistant professors to the research group of Veterinary Anatomy and Pathology, Section of Pathobiology, Department of Veterinary and Animal Sciences to commence 1 January 2025 or after agreement. Information on the Department can be found at: Job description We are looking for highly motivated and...


  • København Huse, Denmark Abbott Laboratories AS Full time

    Job Title: Key Account Manager DenmarkAbout the Role:The Key Account Manager will be responsible for delivering revenue objectives in the Vascular division and strengthening our position in preparation for future launches in Denmark and Norway.Key Responsibilities:Develop and deliver on call plans and account plans to meet agreed revenue targets.Propose...


  • København, Denmark ReFlow Full time

    ReFlow Remote Work Freelance Salary Competitive Are you passionate about sustainability and eager to apply your technical skills to make a real impact? ReFlow, a leading environmental engineering firm, seeks a motivated and talented Sustainability Data Scientist to join our team for the summer of 2024. At ReFlow, we specialize in lifecycle assessment (LCA)...