Manufacturing Process Specialist

11 hours ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Our purpose at AGC Biologics is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow.

Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth?

As a Contract Development and Manufacturing Organization (CDMO), we manufacture drugs for a variety of customers. Depending on customer needs, this can be for drugs ranging from development to clinical and commercial production. Right now, you have the opportunity to join our Commercial, Microbial teams as a Scientist responsible for supporting the production line with error-free and timely execution and owning batch documentation, review, and deviation handling.

The team has in-depth knowledge of product-specific requirements and owns the production process of all buffers and media for production. This includes facilitating solutions on how to proceed during breakdowns during batch execution, establishing and maintaining procedures to ensure compliance, and capturing learnings and implementing continuous improvements to processes.

Responsibilities:

  1. Creating and reviewing Master Production Records.
  2. Supporting the production team and providing on-the-line support during critical process steps.
  3. Facilitating solutions on how to proceed during breakdowns during batch execution.
  4. Establishing and maintaining procedures to ensure compliance.
  5. Capturing learnings and implementing continuous improvements to processes.
  6. Providing audit and inspection support.
  7. Representing the company in customer meetings and communications.

Requirements and Qualifications:

The ideal candidate holds an academic degree within life sciences and has previously worked in a manufacturing team operating under cGMP, preferably within the pharmaceutical industry. The ideal candidate for this position has several of the below competencies/experiences:

  1. A Master's or Bachelor's Degree in natural or life science-related fields.
  2. Knowledge of upstream or downstream processes.
  3. Experience writing, reviewing, and approving GMP documentation.
  4. Experience with operations of single-use technologies and aseptic processing.
  5. Self-motivated, organized, and proactive.
  6. Ability to coordinate multi-departmental tasks and deliverables.
  7. Experience working with multiple projects simultaneously.
  8. Demonstrated experience leading troubleshooting efforts.
  9. Strong communication skills necessary to interact with internal and external stakeholders.

Benefits:

At AGC Biologics, you will get a unique opportunity to work with a variety of state-of-the-art technologies among +40 different nationalities. This opens many doors for personal development and for making a real difference towards both patients, customers, and your own development. We offer an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. Our employees are flexible and take pride in working together to achieve goals - as one team.

Our Culture:

AGC Biologics is defined by 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.



  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Manufacturing Process Development Specialist to join our team in Bagsværd, Denmark.The successful candidate will have expertise in enzyme chemistry, enzyme (protein) recovery and purification, separation techniques like filtration, chromatography, and precipitation.You will be responsible for optimizing enzyme...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionWe are seeking a highly skilled Biologics Manufacturing Specialist to join our team at AGC Biologics. This is an exciting opportunity to work with cutting-edge technologies and contribute to the development of life-changing therapies for patients around the globe.About AGC BiologicsAGC Biologics is a leading global biopharmaceutical Contract...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    At Novo Nordisk A/S, we are committed to creating a better future for people living with serious diseases. Our innovative medicines and solutions are designed to improve the lives of millions of patients worldwide. As a Junior Process Supporter in our Pharmaceutical Manufacturing team, you will play a crucial role in ensuring the quality and safety of our...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the Role:As a Quality Assurance Specialist at AGC Biologics, you will play a critical role in ensuring the highest quality standards are met in our biopharmaceutical manufacturing processes. Located at our Copenhagen Site, this position offers an exciting opportunity to contribute to the development of life-changing therapies for patients...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Cell Line Development SpecialistWe are seeking a skilled Cell Line Development Specialist to join our team at AGC Biologics. This role involves developing and optimizing mammalian cell lines for biopharmaceutical manufacturing, working closely with cross-functional teams to achieve project goals.About the RoleIn this critical position, you will design and...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewThis role is an exciting opportunity to join the manufacturing team at AGC Biologics as a Scientist in the Commercial Microbial department.About the RoleWe are seeking a highly skilled and experienced scientist with expertise in process support to join our team. As a key member of the production team, you will be responsible for ensuring smooth...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Take your career to the next level at AGC Biologics, a global leader in biopharmaceutical Contract Development and Manufacturing Organization (CDMO).We are currently seeking an experienced Biotech Process Specialist to join our Copenhagen Site team. This exciting opportunity will allow you to work on fast-track projects and rare diseases, leveraging your...


  • Gladsaxe, Gladsaxe Municipality, Denmark GEA Process Engineering Full time

    Job DescriptionWe are seeking a highly motivated Digital Communication Specialist to join our team at GEA Process Engineering in Soeborg, Denmark.About the Job:The ideal candidate will have strong communication skills and be comfortable with responsibility.You will work closely with our international team of digital specialists to create engaging content for...


  • Gladsaxe, Gladsaxe Municipality, Denmark European Energy AS Full time

    About European Energy A/SEuropean Energy A/S is a Danish privately owned company founded in 2004 with headquarters in Copenhagen. We operate all the way from development, design, financing, construction, operation and selling of wind- and solar farms on land as well as off shore globally.SalaryThe estimated salary for this position is around DKK 850,000 -...


  • Gladsaxe, Gladsaxe Municipality, Denmark European Energy AS Full time

    About European EnergyEuropean Energy A/S is a rapidly growing Danish company with a global presence, specializing in the development and operation of renewable energy projects. With over 780 employees from 41 nationalities, we are committed to being a leading partner in the green transition.Job OverviewWe are seeking an experienced Business Process...

  • QA Specialist

    2 weeks ago


    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the Role">We are seeking a skilled QA specialist to join our team at Novo Nordisk's Aseptic Manufacturing Science and Technology (AMSAT) department. As a key member of our quality unit, you will play a vital role in ensuring patient safety by delivering high-quality standards for our products and production processes. ">The Position ">As a QA...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    We are seeking a highly skilled Maskinmester/Marine Engineer to join our production sites in Denmark. As a key member of our support team, you will play a crucial role in shaping the future of manufacturing across the organization.About Novo Nordisk A/SNovo Nordisk is a global healthcare company employing over 60,000 employees worldwide. We are committed to...


  • Gladsaxe, Gladsaxe Municipality, Denmark GEA Process Engineering Full time

    GEA Process Engineering is a leading global company in the food and beverage processing industry. With over 18,000 employees across more than 60 countries, our company offers a wide range of opportunities for growth and development.We are seeking a talented student worker to join our Digital Channels team at GEA's headquarters in Soeborg, Denmark. As a key...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the Role">We are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. This is an exciting opportunity for someone who is passionate about quality and safety in pharmaceutical manufacturing.">Job Summary">The successful candidate will be responsible for ensuring patient safety by delivering high-quality standards for...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Unlock a World of Possibilities in Biopharmaceutical DevelopmentWe are seeking a talented Upstream Process Transfer Scientist to join our dynamic team at AGC Biologics in Copenhagen. As a key member of our Process Transfer Department, you will play a crucial role in the successful transfer of upstream processes from development to manufacturing, ensuring...


  • Gladsaxe, Gladsaxe Municipality, Denmark Alfa Laval Full time

    Job DescriptionWe are seeking a skilled Project Engineer to drive the technical aspects of our customer projects at Alfa Laval, based in Copenhagen. As a key member of our project team, you will be responsible for system engineering and involved in all project phases.Key Responsibilities:Develop detailed drawings and designs using Inventor and AutoCAD,...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionWe are seeking an experienced Upstream Process Transfer Scientist to join our dynamic department under MSAT unit at AGC Biologics in Copenhagen.About the RoleIn this role, you will play a key part in the successful transfer of upstream processes from development to manufacturing or form our clients into AGC Biologics manufacturing, ensuring...

  • Mechanical Engineer

    2 weeks ago


    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    At Novo Nordisk, a global leader in pharmaceutical manufacturing, we are seeking a highly skilled Mechanical Engineer to join our team in Bagsværd, Denmark.The successful candidate will be responsible for ensuring the optimal performance of our production systems, including HVAC, process air, and ammonia systems. This will involve identifying and addressing...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Company Overview:Novo Nordisk A/S is a global healthcare company that discovers, develops, and manufactures innovative medicines to improve the quality of life for patients.Estimated Salary: 85,000 - 110,000 DKK per annumJob Description:As an Advanced Procurement Professional at Novo Nordisk, you will play a key role in supporting the procurement process and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job OverviewWe are seeking a talented and detail-oriented Pharmaceutical Process Optimization Specialist to join our team at Novo Nordisk A/S. As a key member of our production and development sites, you will play a vital role in optimizing pharmaceutical processes, developing monitoring tools, and analyzing data for recommendations for improvements and...