Scientist, Manufacturing

2 months ago

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.

Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.
As a CDMO, AGC Biologics manufactures 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 the Manufacturing Product Support department as a Scientist in one of our Commercial, Microbial teams. This position requires technical problem-solving, process understanding, and inter-departmental collaboration.

The team owns the production process of all buffers and media for production. This includes 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 the product-specific requirements.

RESPONSIBILITIES:

  1. Accountable for creating the Master Production Record.
  2. Responsible for reviewing Master Production Record.
  3. Responsible for support to the production.
  4. On-call/shop floor scientist to ensure on-the-line support during critical process steps.
  5. Responsible for facilitating solutions on how to proceed during breakdowns during batch execution.
  6. Accountable for timely deviation closure (including systematic problem-solving during root cause investigation) as well as other quality documents.
  7. Establish and maintain procedures to ensure compliance.

Other:

  1. Customer meeting representative.
  2. Audits and inspection support.
  3. Responsible for capturing learnings and implementing continuous improvements to processes.
  4. Knowledge about requirements for relevant products.

EDUCATION AND EXPERIENCE:
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 the position has several of the below competencies/experiences:

  1. Masters or Bachelors Degree in natural or life science related fields.
  2. Knowledge of upstream or/and downstream processes.
  3. Preferably have experience writing, reviewing, and approving GMP documentation.
  4. Preferably experience with operations of single-use technologies and aseptic processing.
  5. Preferably experience in clinical/commercial GMP manufacturing.
  6. Self-motivated, organized, and proactive.
  7. Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Validation, Engineering, QA, QC, etc.).
  8. Experience working with multiple projects simultaneously.
  9. Demonstrated experience leading troubleshooting efforts.
  10. Strong communication skills necessary to interact with internal and external stakeholders.

At AGC Biologics, you will get a unique opportunity working with a variety of state-of-the-art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers, and your own development. AGC offers 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. AGC employees are flexible and take pride in working together to achieve goals - 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.

Location: Copenhagen Site

#J-18808-Ljbffr

  • Scientist, Manufacturing

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Transforming Lives through Innovative ManufacturingAt AGC Biologics, we're dedicated to bringing hope to life by enabling life-changing therapies for patients worldwide. As a Scientist, Manufacturing, you'll play a vital role in our mission to create a healthier and happier tomorrow.About the RoleWe're seeking a highly skilled and motivated individual to...

  • Development Scientist

    4 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Development Scientist to join our API Manufacturing Development team at Novo Nordisk. As a key member of our team, you will be responsible for handling enzyme manufacturing process optimization, supporting enzyme production facilities, and preparing and maintaining development documentation.Your Key...

  • Scientist in Enzyme Manufacturing

    2 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a talented Scientist in Enzyme Manufacturing to join our team at Novo Nordisk A/S. The successful candidate will be responsible for handling enzyme manufacturing process optimization, supporting enzyme production facilities, and preparing development documentation.Main ResponsibilitiesEnzyme manufacturing process...

  • Scientist, Manufacturing Specialist

    4 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    At AGC Biologics, we're committed to delivering high-quality biopharmaceuticals to patients around the globe. As a Scientist, Manufacturing Specialist, you'll play a critical role in ensuring the success of our manufacturing processes. Key Responsibilities: Develop and implement manufacturing processes to meet customer requirements.Collaborate with...

  • Scientist, QA Manufacturing Support

    2 months ago

    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. The QA Manufacturing Support Scientist is responsible for quality...

  • Scientist, Manufacturing Specialist

    2 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a talented Scientist to join our Manufacturing Product Support department at AGC Biologics. This is an exciting opportunity for a skilled professional to contribute to the production process of buffers and media for commercial production.The ideal candidate will have experience working in a cGMP environment and be proficient in...

  • Scientist, QA Manufacturing Support Specialist

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our mission is to work side by side with our customers to improve patients' lives by bringing new biopharmaceuticals to market.The QA Manufacturing Support Scientist plays a crucial role in ensuring manufacturing compliance with applicable procedures and GMP requirements.Key Responsibilities:Provide real-time quality support to manufacturing operations,...

  • Scientist, QA Manufacturing Support Specialist

    4 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Transforming Lives through Quality ExcellenceAt AGC Biologics, we are committed to delivering life-changing therapies to patients worldwide. As a QA Manufacturing Support Scientist, you will play a vital role in ensuring the quality and compliance of our manufacturing operations.Key Responsibilities:Provide real-time quality support to manufacturing teams,...

  • QC Bioassay Senior Scientist

    2 months ago

    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...

  • Scientist Manufacturing Product Support

    2 months ago

    Gladsaxe Kommune, Denmark AGC Biologics Full time

    As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be drugs ranging from development, to clinical and commercial production. Right now, you have the opportunity to join the Manufacturing Product Support department as we have several open positions across the department within upstream,...

  • 12 months Temporary Scientist

    2 months ago

    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 is looking for a Scientist / Sen. Scientist with expertise and...

  • Senior Scientist, Quality Assurance Specialist

    1 month ago

    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 QA Scientist, you will play a vital role in ensuring the quality and compliance of our manufacturing processes and facilities.Key Responsibilities: As a QA Scientist, your primary responsibilities will include:Reviewing and approving...

  • Senior Scientist, Quality Assurance

    2 months ago

    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...

  • Development Scientist

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Development Scientist to join our API Manufacturing Development team at Novo Nordisk A/S. As a key member of our team, you will be responsible for optimizing enzyme manufacturing processes, supporting enzyme production facilities, and preparing development documentation.Key ResponsibilitiesOptimize enzyme...

  • Development Scientist

    1 month ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Development Scientist to join our API Manufacturing Development team at Novo Nordisk A/S. As a key member of our team, you will be responsible for optimizing enzyme manufacturing processes, supporting enzyme production facilities, and preparing development documentation.Key ResponsibilitiesOptimize enzyme...

  • Associate Principal Scientist, Quality Assurance

    2 months ago

    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...

  • Senior Scientist, Quality Assurance Specialist

    2 months ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job Title: Senior Scientist, Quality AssuranceWe are seeking a highly motivated and experienced Senior Scientist to join our Quality Assurance team at AGC Biologics. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Oversee the Quality Assurance review and approval...

  • Senior Scientist, Quality Assurance Expert

    4 weeks ago

    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...

  • Quality Assurance Specialist for Manufacturing Operations

    2 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    At AGC Biologics, we strive to bring hope to life by enabling life-changing therapies for patients worldwide.Our QA Manufacturing Support Scientist plays a vital role in ensuring the quality and integrity of our manufacturing processes.The key responsibilities of this position include:Providing real-time quality support to manufacturing operations, ensuring...

  • Associate Principal Scientist, Quality Assurance Specialist

    1 month ago

    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,...