Biotechnology Specialist
2 days ago
The Novo Nordisk Foundation Cellerator is seeking a seasoned analytical and quality control professional to spearhead the development of cell-based therapies. As a Biotechnology Specialist, you will play a crucial role in designing and implementing analytical strategies, providing expertise on assay development, and ensuring regulatory compliance.
With a strong background in cell therapy, stem cell biology, or closely related fields, you will bring your expertise to our team and contribute to the acceleration of cell-based therapies towards clinical trials within Denmark's cell therapy ecosystem and beyond.
Your key responsibilities will include:
- Subject Matter Expertise: Provide analytical guidance and expertise on assay development for quality control during development, manufacture, and release of cell therapy products
- Laboratory Design: Accountable for design and equipment for QC and analytical development laboratories
- Standard Operating Procedures: Develop and maintain standard operating procedures, study plans, drug substance/drug product specifications, protocols, and method development reports within assay development and quality control
- Collaboration and Training: Train other personnel within assay development and QC and support transfer of analytical test methods (into/out of Cellerator and from development laboratories to GMP performance internally in Cellerator)
We are looking for a highly motivated individual with excellent stakeholder management skills, a structured approach, and the ability to analyze and interpret complex data. If you have a passion for regenerative medicine and a desire to make a meaningful impact, we encourage you to apply.
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Biotechnology Development Specialist
2 days ago
Copenhagen, Copenhagen, Denmark AGC Biologics Full timeAbout the RoleAs a Biotechnology Development Specialist at AGC Biologics, you will be part of our dynamic QA or Manufacturing department. Your primary responsibility will be to ensure the highest standards of quality in our production processes.Key Responsibilities:Master Production Record Management: Create, review, and maintain Master Production...
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Pharmaceutical Regulatory Affairs Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeRegulatory Affairs Document SpecialistWe are seeking a highly skilled Regulatory Affairs Document Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6,...
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Pharma Biotech Automation Specialist
1 day ago
Copenhagen, Copenhagen, Denmark Optimus Search Full timeWe are looking for a highly skilled Pharma Biotech Automation Specialist to join our team on a large-scale project. The successful candidate will have experience working with DCS systems, preferably Emerson DeltaV, and a strong understanding of automation and batch processes.In this role, you will be responsible for developing and executing automation...
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Senior Regulatory IT System Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is a pioneering biotechnology company transforming the lives of patients through innovative cancer treatment and antibody therapeutics. We're seeking a Senior Regulatory IT System Specialist to join our team in maintaining, developing, and operating our enterprise electronic document management system (EDMS), GenDocs.As a key member of our Digital...
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CMC Analytical Specialist
1 week 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...
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Clinical Documentation Consultant
4 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeClinical Documents SpecialistWe are looking for a skilled Clinical Documents Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated summaries of...
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Medical Writing Expert Consultant
4 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeClinical Documentation SpecialistWe are looking for a skilled Clinical Documentation Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated...
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Senior Medical Content Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeMedical Writing Expert ConsultantWe are seeking an experienced Medical Writing Expert Consultant to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will work as a consultant to support our clients in the pharmaceutical, biotechnology, and medical device industries. You will be responsible for writing and reviewing clinical...
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Household Care Application Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Novonesis Full timeWe need your talent, knowledge, and dedication to better our world with biology. As an Application Scientist in HHC-AR at Novonesis, you will be working on the development of enzyme solutions for future detergents.Your responsibilities will include designing and managing research experiments, investigating substrate removal by enzymes, and understanding...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the Role Genmab is now searching for two (Senior) CMC Technical Integration Managers to join the CMC Integration Team in New Product Introduction (NPI) CMC. The NPI team is responsible for Early-Stage CMC development covering preclinical to early/mid clinical stage CMC work. Key Responsibilities Include:Integration of new/specific required...
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Manufacturing Scale Equipment Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Alba Project Group Full timeAs a Downstream Process Engineer, you'll play a key role in driving innovation and delivering exceptional results with professionalism and trust. You'll have the opportunity to lead with expertise, build lasting relationships, and collaborate with talented colleagues.The ideal candidate will have a strong educational background, with a Master's degree in...
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System developer
15 hours ago
Copenhagen, Copenhagen, Denmark Isynet Full timeWe are looking for a System developer that can take part in designing and building systems that help 90+ people to be more efficient in their daily work in a consultancy company working in the pharmaceutical and biotechnology industry.About the jobYou will be working in Isynet, supporting our in-house IT development and operations team to ensure smooth...
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Fermentation Process Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Again Full timeAbout AgainWe're a growing company committed to developing innovative bioprocesses for sustainable chemical production. As a leader in the field, we're looking for an experienced professional to oversee our fermentation activities and drive technological advancements.Key ResponsibilitiesTranslate overall strategy into specific objectives and tasks for the...
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Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timePassionate about Quality Assurance with expertise within outsourced GMP activities and development projects? Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...
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Corporate Alliance Specialist
7 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeNovo Nordisk is a global leader in the development of innovative medicines and solutions for people living with chronic diseases.Director/Associate Director Corporate Alliance Management (Maternity Cover - 12 months)Category: Business Development & StrategyWe are seeking a talented professional to join our Corporate Alliance Management team, responsible for...
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Outbound Engagement Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Reshape Biotech Full timeAbout Reshape BiotechWe're revolutionizing biotechnology research through innovative automation and AI technology.We provide research teams with automated lab processes, real-time data capture, and actionable insights, enabling them to accelerate breakthrough product development.Our Sales team plays a vital role in this journey, and as a key member, you'll...
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Danish speaking QA/QMS Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeIn our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating...
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Clinical Trial Disclosure Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout UsGenmab is an international biotechnology company driven by its core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. Our team strives towards transforming cancer treatment and serious diseases, fostering a collaborative environment where employees can thrive.As a Sr. Associate/Manager in our...
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Automation Engineer
1 day ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeGet AI-powered advice on this job and more exclusive features. Direct message the job poster from Black Swans Exist Helping ambitious Life Science firms access the best niche talent in the Nordics | Recruitment | Executive Search | Medtech | Pharma | Biotech Experienced MES Syncade/PAS-X Automation Engineer for In-House MES Team On behalf of a leading...
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Global Project Controls Consultant
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