Senior Scientist Drug Product Analysis and Stability
4 days ago
Select how often (in days) to receive an alert:
Senior Scientist Drug Product Analysis and StabilityField of work: Research
Posting Date: 27 Jan 2025
Would you like to engage in complex projects that challenge your skills and expand your expertise in analytical chemistry and pharmaceutical science, and be part of a professional environment that values innovation, quality, and scientific excellence? Then this is the perfect opportunity for you
LEO Pharma is looking for a dedicated and experienced Analytical Senior Scientist to join our Products & Processes team in Ballerup, Denmark. Here you will be part of a small team that is committed to improving the lives of patients around the world. Our department is known for its great collaborative spirit. You will work alongside talented scientists and technicians who are passionate about their work and supportive of each other's growth and success.
Your role
As an Analytical Senior Scientist, you will play a crucial role in the development and validation of analytical methods, stability studies, and regulatory submissions.
Your responsibilities will include:
- Contribute to complex development projects and ensure timely delivery of high-quality scientific work within your area of expertise.
- Set up and follow up on stability studies, data trending, and handling OOS/OOT and SNT.
- Drive deviation, change control, and CAPAs.
- Plan and follow up on analytical work in the laboratory, including internal collaborations and with CDMO/CMOs.
- Develop analytical methods, specifications, and control strategies for projects during development.
- Prepare, review, and approve documentation such as electronic lab notes, protocols, reports, analytical methods, SOPs, and work instructions.
- Write regulatory documentation for regulatory submission of IMPD, NDA, MAA, and elaborate replies to health authorities.
In addition to these primary tasks, you will also be supporting GMP and regulatory compliance.
Who are you?
We are looking for you who can bring a collaborative attitude, innovative mindset, and passion for contributing to the development of life-changing medicines and improving patient outcomes globally.
- A Ph.D. or a Master's degree with a focus on analytical chemistry and pharmaceutical science, or equivalent education with relevant practical experience.
- 5+ years of work experience in analytical chemistry and stability, with full knowledge of pharmaceutical industry standards and practices.
- Proven track record in method development, stability studies, and trending on stability data.
- Experience in preparing regulatory documentation and ensuring compliance with regulations.
Join a workplace that fosters a culture of trust, courage, and making a positive impact.
Contact and application
For additional information, please contact the hiring Manager at +45 30491416.
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.
#J-18808-Ljbffr-
Drug Product Manager
2 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeDo you want to play an essential role in ensuring drug product quality throughout its lifecycle and in supporting Novo Nordisk's production of high quality, world-leading diabetes and obesity products? Are you motivated by cross team collaboration, driving optimization and ready to change the game together with colleagues in a dynamic department? Then this...
-
Senior QC Scientist
1 week ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeSenior 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? ...
-
Senior Research Scientist
4 days ago
Copenhagen, Copenhagen, Denmark Københavns Universitet (KU) Full timeAbout the PositionWe are pleased to offer a fixed-term position as a Senior Research Scientist - Chromosome Stability at the Center for Chromosome Stability (CCS) at Københavns Universitet (KU).The position is available from 1st January 2025 or after agreement and is limited to a period of 8 months. The average weekly working hours are 37 hours per week.The...
-
Regulatory Affairs Scientist
7 days ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout UsC. H. Lundbeck A/S is a leading global pharmaceutical company that has been active in the production of drugs for more than 70 years. Our main goal is to develop and commercialize treatments for brain diseases. We are committed to delivering innovative treatments to patients around the world.Job DescriptionWe are seeking a highly skilled Senior...
-
Senior Research Scientist
5 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeLundbeck A/S, H is a Danish pharmaceutical company that develops innovative treatments for brain disorders. As a Senior Research Scientist, you will join the Department of Drug Metabolism within the Non-Clinical Safety Research division.Your key responsibilities will involve evaluating the drug-drug interaction risk of Lundbeck development compounds,...
-
Research Scientist
12 hours ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeLundbeck is a global leader in the discovery, development, and commercialization of innovative treatments for brain diseases. As a Research Scientist in our Pharmaceutical Development team, you will be part of our mission to restore healthy mental well-being for every person.We are currently seeking an experienced pharmaceutical specialist with a strong...
-
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeLundbeck A/S, H is seeking a highly skilled QC Expert for Drug-Device Combination Products to join our international CMC Biologics team. As our new expert, you will be responsible for ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team.You will work closely with...
-
Senior Quality Assurance Specialist
7 days ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeCompany OverviewC. H. Lundbeck A/S is a global pharmaceutical company that has been active in the production of drugs for more than 70 years. Our main goal is to develop and commercialize treatments for brain diseases.Job DescriptionWe are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics Quality Control team. As a member of...
-
Research Scientist
5 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeAbout Our TeamWe are a team of scientists and experts who work together to provide biophysical characterization support to production sites around the world. We are passionate about our work and strive to deliver high-quality results in a fast-paced environment.Job DescriptionThe successful candidate will be responsible for:Supporting production sites with...
-
Biologics QC Team Lead
7 days ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeJob RequirementsTo be successful in this role, you will need to have a deep understanding of Quality Control processes and procedures, as well as excellent communication and collaboration skills. You will also need to be able to work effectively in a fast-paced environment with changing priorities.About the RoleThis is an exciting opportunity to join a...
-
Senior CMC Stability Associate
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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...
-
Senior Associate CMC for the Stability Team
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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...
-
Senior Scientist, QC Bioassay
2 days ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeSenior Scientist, QC Bioassay - Evening/Night Senior Scientist, QC Bioassay - Evening/Night Apply locations Copenhagen, Denmark time type Full time posted on Posted 2 Days Ago job requisition id JR101735 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...
-
Senior Scientist
7 days ago
Copenhagen, Copenhagen, Denmark Københavns Universitet Full timeWe are recruiting a senior scientist to join our Chromatin Replication and Epigenome Maintenance research group. The successful candidate will work on elucidating how chromatin organization and function is propagated during mitotic cell division to maintain genome and epigenome stability.The senior scientist will be responsible for:Leading projects in...
-
Senior Scientist, QA Mammalian
2 days ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeSenior Scientist, QA Mammalian Senior Scientist, QA Mammalian Apply locations Copenhagen, Denmark time type Full time posted on Posted 4 Days Ago job requisition id JR101647 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 Scientist, QC Bioassay
7 hours ago
Copenhagen, Copenhagen, Denmark AGC Biologics Full timeSenior Scientist, QC Bioassay - Evening/NightSenior Scientist, QC Bioassay - Evening/NightApply locations Copenhagen, Denmark time type Full time posted on Posted 7 Days Ago job requisition id JR101735Our 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...
-
Senior Associate CMC Stability Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAs a Senior Associate CMC for the Stability Team, you will play a crucial role in ensuring the stability of our products during clinical development and commercialization. Your expertise will help us maintain compliance with regulatory requirements and ensure the quality of our products.In this role, you will collaborate with the CMC Project Manager, QA, and...
-
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeDo 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...
-
Drug Product Development Expert
12 hours ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAre you looking for a challenging role in Pharmaceutical Development? Do you have a strong scientific background in physicochemical science, preclinical and/or early phase formulation development and biopharmaceutical science?H. Lundbeck A/S is seeking a highly skilled Drug Product Development Expert to join our Pharmaceutical Development team. In this role,...
-
Senior Upstream Scientist
5 days ago
Copenhagen, Copenhagen, Denmark Blackswansexist Full timeJob 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...