GMP-Expert

At Y-mAbs Therapeutics, we are dedicated to becoming a world leader in developing innovative radioimmunotherapy and antibody-based oncology products. As part of our Global Quality Assurance team, you will play a crucial role in maintaining and continuously improving our company's Quality Management System.About the RoleThe Senior Manager, GMP Global QA will...

Our vision for the future is to be a leading company in the industry of pharmaceuticals and healthcare products. To achieve this goal, we are seeking a highly motivated and skilled professional to join our team as a Senior Laboratory Technician with GMP experience.As a member of our Quality Control Environmental monitoring, Microbiology & Cleanrooms (QC...

We are looking for a Manager of Pharmaceutical Operations who can inspire, mentor, and develop a team of experts in drug substance development. As a seasoned professional with a strong scientific background, you will lead our team in developing innovative solutions for protein and biologic development.The Manager of Pharmaceutical Operations will work...

Product Regulatory ExpertWe are seeking a Product Regulatory Expert to support the development of regulatory compliant and technically relevant solutions.About the RoleThe position is part of the Regulatory Intelligence & Conformity (RIC) Team at VELUX Group, focusing on ensuring the long-term technical and regulatory relevance of our product offerings.Your...

ALK-Abelló A/S is a health-focused organization that values pioneering spirit, credibility, and collaboration. As the Leader of Biologics Development, you will play a critical role in shaping our company's future by leading the development of robust and scalable drug substance processes.Our Leader of Biologics Development will have a minimum of 7 years of...

At ALK-Abelló A/S, we are seeking an experienced leader to oversee our drug substance development operations. As the Senior Director of Drug Substance Development, you will be responsible for leading a team of skilled scientists and technicians in the development of robust and scalable drug substance processes.The ideal candidate will have a minimum of 7...

Velux Deutschland GmbH is seeking a Regulatory Affairs Expert to join their Regulatory Intelligence & Conformity (RIC) Team. As a key member of the team, you will be responsible for monitoring and interpreting current and upcoming EU legislations, engaging stakeholders, and communicating your findings to both specialists and non-specialists.About the JobYou...

Role SummaryClinical Disclosure Expert is responsible for providing clinical disclosure guidance to development projects across the product portfolio. This role will contribute to the development of the clinical disclosure landscape and enhance the concept of transparency by design at ALK.**Key Responsibilities:**Write and prepare complex scientific and...

Company OverviewNovonesisAt Novonesis, we recognize the potential of biology-based solutions to address humanity's most pressing challenges. Our mission is to drive sustainable change through innovative biosolutions. We're committed to creating a diverse and inclusive environment where talented individuals can thrive.Job DescriptionTech Expert RoleWe're...

Job OverviewThe VELUX Group offers a unique opportunity to utilize your technical expertise as a Quality Engineer in New Product Introduction.We seek an individual with systematic thinking and thorough analysis skills to excel in this role.Main ResponsibilitiesDevelop BIQ Solutions: Create high-quality products by designing and implementing Build-in-quality...

Key Responsibilities:Prepare and handle regulatory CMC documentation for submissions to authorities globally, ensuring compliance with relevant regulations and guidelines.Develop and maintain regulatory CMC documentation for initial and life cycle submissions for strategic products, collaborating with cross-functional teams to ensure seamless...

Role OverviewWe are seeking an exceptional Numerical Modelling Expert to drive our efforts in green transformation.This is a unique opportunity to join our team and contribute to the development of innovative solutions in numerical modelling, specifically in CFD.

Få et spændende job med stor mulighed for selv at påvirke og optimere afdelingens GMP-niveauSom GMP Supporter er du en del af teamet Operationel Technology i området Engineering, Projects & Maintenance. Vi er ansvarlige for teknisk support til vores produktionssite i Hørsholm, hvor vi sikrer, at alle utilities, automationsløsninger og...

Job SummaryWe are seeking a highly skilled Laboratory Equipment Qualification Expert to join our team in Laboratory Automation Development. As a key member of our department, you will be responsible for performing qualification and implementation of new analytical instruments and validation of computerized systems. If you have a passion for IT systems,...

At Epista, we're expanding our team of experts in Computer System Validation (CSV) and transitioning to Computer Software Assurance (CSA). This shift towards CSA is driven by the FDA's recommendations and the new GAMP edition. As a CSV consultant, you'll play a crucial role in helping Life Science companies adapt to these changes and maintain...

Y-mAbs Therapeutics is a biopharmaceutical company dedicated to developing innovative treatments for cancer. We are seeking a highly skilled Senior Manager, GMP Global QA to join our Global QA team.About the PositionThe Senior Manager, GMP Global QA will be responsible for ensuring compliance with regulatory requirements and industry standards. This includes...

We are seeking a skilled Senior Manager, GMP Global QA to join our Global QA team at Y-mAbs Therapeutics. As a member of our organization, you will contribute to the development and commercialization of cutting-edge therapies to treat various cancers.Job OverviewThe Senior Manager, GMP Global QA will be responsible for maintaining and improving our company's...

About the RoleWe are seeking a skilled Automation Expert to join our team in Laboratory Automation Development at ALK-Abello. As a key member of our department, you will be responsible for qualifying and implementing new analytical instruments, as well as validating computerized systems.Key Responsibilities:Perform qualification and implementation of new...

Brænder du for at være en drivende kraft bag utilities som understøtter vores farmaceutiske produktionsfaciliteter?Inden for denne rolle som Senior utility udstyrsejer, vil du få mulighed for at udleve dine faglige evner og bidrage til at optimere og forny vores udstyr.Dit arbejdeI Engineering, Projects & Maintenance er vi 28 medarbejdere hvis...

Er du interesseret i at være ansvarlig for at opretholde utilities som vand, ventilation og trykluft til vores farmaceutiske produktionsfaciliteter? Har du erfaring med teknisk support?Jobbeskrivelse:Som Senior utility system operator vil du få en spændende og varierende stilling med mulighed for at bringe dine egne erfaringer tilbage. Du vil arbejde på...