Senior QC Scientist

3 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?
As our Senior Quality Control Scientist, you will be:

  1. Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products
  2. Working closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, e.g., sampling plans, Certificate of Analysis, stability studies, method validation etc.
  3. Reviewing and approving protocols, reports, and other documents for studies performed internally and at contract laboratories
  4. Collaborating within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs
  5. Supporting regulatory filings and other interactions with Health Authorities

This position is a great opportunity where you will be part of a team ensuring the quality of Lundbeck’s development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team. Some travelling, on average 2-4 trips per year, is estimated in this role.

Your future team
In CMC Biologics, we are more than 100 employees, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Process Development Center of Excellence in Seattle, WA, USA. Most of the teams in the CMC Biologics organization has employees based in both Copenhagen and Seattle; this is also the case for your new department, Quality Control. You will work out of the headquarter in Valby, Copenhagen, and will report to the Senior Manager Quality Control, in Valby. Your colleagues in the Quality Control team are all experienced specialists, and together we are responsible for the quality of Cell Banks, Drug Substance, and Drug Product for all Lundbeck development biological projects.

CMC Biologics support the development and production of new biologics drug candidates for diseases like Migraine, Parkinson’s, and neurohormonal dysfunctions. Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbeck’s Biologics candidates and are working in global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial.

As our team is located both in Copenhagen and Seattle, it is necessary to accommodate to the time zone difference for meetings. We aim to reduce late meetings to a minimum by maintaining a primary meeting band in the calendar and by applying a geographical proximity, when working with our global CMOs.

The position is based in Valby, Copenhagen - Denmark.

What you bring to the team
You are a highly skilled Senior Quality Control Scientist with minimum 5 years of experience in the biotech or pharmaceutical industry. You have an accredited bachelor’s degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal. In addition, you bring:

  1. Experience in drug-device combination products
  2. Good understanding of GDP/GMP guidelines
  3. Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia
  4. Understanding of methods used to test biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA)
  5. Advanced English verbal and written communication skills

As a person, you enjoy working in cross-functional teams and have the ability to work effectively in matrix teams in a fast-paced environment with changing priorities. You have effective verbal communication and collaboration skills, along with good written communication skills and the ability to summarize scientific data in an organized, clear, and persuasive manner. In addition, you bring a quality mindset, and you are motivated by teamwork, openness, continuous improvement, and career development. Candidates fulfilling most but not all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications.

Our promise to you
Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Apply now
Can you see yourself as our new Senior Quality Control Scientist? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you

Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Trine Christensen, Senior Manager Quality Control by email Applications must be received by 09 August 2024, and they will be reviewed on an on-going basis.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve.

#J-18808-Ljbffr

  • Scientist, Senior/Principal Scientist, Quality Control

    2 months ago

    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...

  • Senior Regulatory Scientist

    3 months ago

    København, Denmark Voisin Consulting SARL Full time

    Senior Regulatory Scientist We are continuing to invest in growing our Nordic business and are now seeking to hire Senior Regulatory Scientists. This role will speak to those who are excited at the pace of change and innovation in Life Science, who want have an appetite to partner the most cutting edge clients and those who want to continuously learn,...

  • Senior Upstream Scientist

    2 weeks ago

    København, Denmark Blackswansexist Full time

    Job Description: Senior Upstream Scientist – MSAT Position Summary We are seeking a skilled Senior Upstream Scientist to join our Process Science / Manufacturing Science and Technology (MSAT) team. In this critical role, you will act as a subject matter expert in cell culture processes, ensuring the successful introduction, transfer, and implementation...

  • Senior Data Scientist

    2 weeks ago

    København, Denmark Carlsberg Group Full time

    Location: Copenhagen, DK Entity / company: Integrated Information Technology (IIT) Senior Data Scientist We are seeking a skilled data scientist to define Carlsberg's data science strategy and lead the creation of advanced analytics and machine learning models to address intricate business challenges at Carlsberg. Great beers, great colleagues, a focus on...

  • Senior Scientist, Quality Assurance

    1 month ago

    København, Denmark AGC Inc Full time

    Senior Scientist, Quality Assurance 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...

  • QA/QC Manager

    2 months 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...

  • Senior Scientist, Late Stage Upstream Process Development

    2 weeks ago

    København, Denmark AGC Inc Full time

    Senior Scientist, Late Stage Upstream Process Development Apply locations: Copenhagen, DenmarkTime type: Full timePosted on: Posted 25 Days AgoTime left to apply: End Date: December 8, 2024 (3 days left to apply)Job requisition id: JR101067 Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a...

  • Senior Safety Data Scientist

    3 months ago

    København, Denmark Lundbeck AS, H Full time

    Your experience with data science might be just what we’re looking for. You can be part of transformational initiatives that will impact the field of patient safety. Your enthusiasm for providing data-based insights will help us progress our understanding of the safety of our products for the benefit of patients. Your skillset and contributions will enable...

  • Senior Safety Data Scientist

    3 months ago

    København, Denmark H. Lundbeck AS Full time

    Your experience with data science might be just what we’re looking for. You can be part of transformational initiatives that will impact the field of patient safety. Your enthusiasm for providing data-based insights will help us progress our understanding of the safety of our products for the benefit of patients. Your skillset and contributions will...

  • Data Scientist

    2 months ago

    København, Denmark Acceleration WPP Group Full time

    Join a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...

  • Data Scientist

    2 months ago

    København, Denmark Acceleration WPP Group Full time

    Join a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...

  • Data Scientist

    2 months ago

    København, Denmark Group M Worldwide Inc. Full time

    Join a growing team of Data Scientists transforming marketing for some of the world's largest brands! Join a team of expert Data Scientists and Consultants at Choreograph, a GroupM company, revolutionizing marketing for the world's biggest brands. We transform data into powerful solutions for complex media and marketing challenges, leveraging cutting-edge...

  • Data Scientist

    3 months ago

    København, Denmark Twoday AS Full time

    Vi er twoday, en international virksomhed med mere end 2.700 mennesker, der ønsker at gøre en forskel. Hver dag udvikler vi virkelig nyttige løsninger, der gør folks dagligdag lidt lettere. Apply here twoday er den førende digitale transformationspartner i Nordeuropa med en global tilstedeværelse. Med cirka 3.000 teknologer samarbejder vi med de mest...

  • Preformulation Scientist/Specialist

    3 months ago

    København, Denmark H. Lundbeck AS Full time

    Preformulation scientist/specialist, Pharmaceutical Development small molecules Lundbeck’s passion is tied to our goal of restoring healthy mental well-being, so that every person can be their best. We strive to make a real difference for patients by developing innovative treatments that improve the lives of people living with brain diseases. We are...

  • Senior Digital Product Owner, CMC, R&D Digital Products

    3 months ago

    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...

  • Senior Digital Product Owner, CMC, R&D Digital Products

    3 months ago

    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...

  • Research Scientist, Department of Functional and Cellular Pharmacology

    3 months ago

    København, Denmark Lundbeck AS, H Full time

    Research Scientist, Department of Functional and Cellular Pharmacology Requisition ID: 5611 Location: Copenhagen, Danish Capital Region, DK Research Scientist, Department of Functional and Cellular Pharmacology If you are looking for a job where the goal is to advance brain health and transform lives for people living with brain diseases and at the same...

  • Senior Data Engineer/Lead

    4 weeks ago

    København, Denmark The HubDanske Bank Full time

    At Monthio, a growing tech company in the financial industry, we are committed to building innovative solutions that empower our clients to make confident, data-driven decisions. We are seeking a new colleague to help us enhance and streamline our data infrastructure, which is crucial for delivering on our scaling targets. Role Overview As a Senior Data...

  • Senior Clinical Research Scientist, Solid Tumor Team

    3 months ago

    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...

  • Research Scientist, Department of Functional and Cellular Pharmacology

    3 months ago

    København, Denmark H. Lundbeck AS Full time

    If you are looking for a job where the goal is to advance brain health and transform lives for people living with brain diseases and at the same time use your experience around cellular assays and your interest in data-handling, you might be our next colleague. The role offers challenging tasks, a clear mission to work towards and a collaborative environment...