GMP Materials Expert

About the Job:The GMP Raw Materials Specialist will be responsible for ensuring regulatory compliance, assessing vendor change notifications, and providing strategic input on raw material-related matters. This role requires collaborating with Supplier Qualification Management, Procurement, QA, and Process Teams to assess material and supplier risks. You will...

Job OverviewWe are seeking a highly skilled Materials Scientist for Raw Material Qualification to join our dynamic team at Novo Nordisk A/S. As a key member of our CMC API Process Operations department, you will play a vital role in ensuring the safety and compliance of GMP materials for clinical trials.About the RoleIn this exciting opportunity, you will be...

About AGC Biologics:We are 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. Our purpose is to bring hope to life by enabling life-changing therapies for patients...

Jobbeskrivelse Placering Søborg, Denmark Jobkategori Manufacturing Ansøg nu Are you ready for a career in the pharmaceutical industry and join a growing area taking part in the development of the future Novo Nordisk product pipeline? Are you looking for an opportunity to apply and develop your skills within raw materials for GMP production, process,...

About UsAt Novo Nordisk A/S, we strive to make a real difference for patients with chronic diseases across the world. Our CMC API Process Operations department is a critical part of this mission, ensuring the safe and compliant GMP materials for clinical trials.The PositionAs a Materials Scientist for Raw Material Qualification, you will be an integral part...

About the Role:The Biopharmaceutical Material Scientist Lead will be responsible for facilitating and evaluating the introduction of new raw materials and single-use systems (SUS) into AGC Biologics. This role requires generating and overseeing Change Requests for the introduction, modification, and discontinuation of raw materials/SUS. You will develop and...

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. Team leader/Manager, Material Science Team Are you an experienced...

About the JobAs a Quality Assurance Scientist at AGC Biologics, you will support Supply Chain, Process Transfer, and QC for late-stage and commercial products.Key responsibilities include closing collaborations with internal stakeholders, change control, deviation handling, and CAPAs, reviewing and approving material specifications, releasing raw materials...

Job DescriptionWe are looking for a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. As a member of our team, you will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.Your key responsibilities will...

Join Our TeamAre you experienced in GMP training and looking for a challenging role that aligns with your skills and passions? Do you want to contribute to improving quality across the company by driving improvement projects and developing new training standards?We are seeking a skilled GMP Training Manager to join our Quality Systems department. As a key...

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...

Job OverviewThe successful candidate will be responsible for securing quality agreements with external suppliers and ensuring that raw materials for our products are used in clinical trials following the information provided to Health Authorities worldwide.Key Qualifications:MSc in Pharmaceutical Sciences, Engineering, Biochemistry, or similar.At least 1...

About the RoleAt Novo Nordisk A/S, we are seeking a skilled and motivated Quality Assurance Expert to join our team. In this role, you will play a crucial part in ensuring patient safety by delivering high-quality standards for our products and production processes.The PositionAs an Aseptic Manufacturing Specialist, your primary task will be to review and...

About the RoleThis position involves supporting CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.You will be responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product...

Job Overview">We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.This role is part of our development...

About the TeamThe Manufacturing Product Support department is responsible for the production process of all buffers and media for commercial production. This includes supporting the production line with error-free and timely execution, owning batch documentation, review, and deviation handling.The team has in-depth knowledge of product-specific requirements...

About AGC BiologicsAGC Biologics is a global Contract Development Manufacturing Organization (CDMO) providing comprehensive biologics manufacturing services. Our team tailors each client's needs for turnkey manufacturing or sophisticated analytical, formulation, and stability services.We have facilities in Europe, Japan, Italy, and the USA, enabling us to...

About the RoleIn this challenging and dynamic environment, you will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.Your key duties will include closing collaborations with internal stakeholders, managing change control, deviations, and CAPAs, reviewing and approving material specifications, and...

We are seeking an Automation Engineer to join our Robotic and Automation team. The position involves creating innovative automated solutions and securing the successful implementation of new technologies in our aseptic manufacturing networks.Responsibilities:Work as a subject matter expert for automation and process control systems.Set requirements, review...

Select how often (in days) to receive an alert: Create AlertExpert in Regulatory Affairs - Primary PackagingCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you ready to take on new challenges in primary packaging development across emerging therapeutic areas and innovative products? Would you like to use...