Chemistry and Manufacturing Control Expert

Job DescriptionThis role offers a unique opportunity to join a dynamic team in a fast-paced, global environment. As a CMC Regulatory Specialist, you will play a critical role in ensuring the successful development and approval of our synthetic small molecule projects. Your expertise in regulatory affairs, combined with your knowledge of synthetic small...

QualificationsA Master and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health authority.A minimum of 8+ years of experience with synthetic small molecules experience is preferred, as well as experience in the following areas:In-depth knowledge of regulatory CMC requirements for clinical...

Company OverviewNovo Nordisk A/S is a dynamic company that drives change in the pharmaceutical industry. We strive for excellence without fixating on perfection and seize opportunities to develop.We are responsible for Quality Assurance of Novo Nordisk's local manufacturing CMOs; we currently consist of eight QA colleagues working closely together, covering...

About UsEuropean Energy A/S is a Danish privately owned company founded in 2004 with headquarters in Copenhagen. We operate all the way from development, design, financing, construction, operation, and selling of wind- and solar farms on land as well as off shore globally. As part of this, we are active in M&A activities across the full value chain.Job...

Key Skills and QualificationsTo succeed as an Upstream Process Transfer Scientist, you should possess:A PhD or M.Sc. in biochemistry, protein chemistry, biotechnology, or a related field.Experience within process development and/or manufacturing within upstream processing.A flexible approach and desire to take on new tasks and responsibilities.Proven...

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 RoleWe are seeking an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our Synthetics & Cell Technologies Department in the RA CMC Biotech & Rare Disease area within Novo Nordisk.The successful candidate will provide strategic, tactical, and operational regulatory input to projects, leading activities...

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 UsNovo Nordisk A/S is a global healthcare company with a strong commitment to improving the quality of life for people around the world. Our mission is to make a meaningful difference in the lives of people affected by chronic and rare diseases.The TeamYou will become part of a great department with many interfaces around the organisation, both in...

As an Upstream Process Transfer Scientist at AGC Biologics, you will be responsible for the transfer of upstream processes from development to manufacturing.This role requires collaboration with cross-functional teams, leadership of technology transfer activities, and provision of technical expertise in upstream bioprocessing.Key responsibilities include...

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...

The Ideal CandidateWe are looking for an experienced Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist with expertise in synthetic small molecules to join our team. The ideal candidate will have a Master's and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health...

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...

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. Are you motivated by leading and participating in coordination and planning...

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...

Are you a Finance professional who is motivated by improving and optimising? Then this is your opportunity to join a rapidly growing company and make an impact by digitalising and standardising our existing workflow and processes while securing internal controls. You will work from our office in Søborg, Copenhagen. European Energy is a green company in...

About the TeamYou will become part of a great department that works in close collaboration with our 5 laboratories responsible for stability and release samples in Denmark. The department consists of 67 people divided into four teams, and this position is in the QA for QC team.The team consists of highly knowledgeable and skilled people, covering the diverse...

Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Legal, Compliance & Audit Ansøg nu Are you ready to take on a corporate legal leadership role to enable Novo Nordisk's production capacity scale up, and thereby help us improve the lives of patients? Do you want to lead an ambitious and high performing legal team supporting Novo Nordisk's Product...

Every day, we get opportunities to make a positive impact – on our colleagues, partners, customers, and society. Together, we're pioneering the solutions of the future and unlocking the full potential of precious resources. Trusted to act on initiative, we challenge conventional thinking to develop world-leading technologies that inspire progress in vital...

Are you ready to support and be part of shaping the future of aseptic manufacturing at Novo Nordisk? Are you motivated by creating smart automated solutions together with your team and the production sites around the world? Then this is a unique opportunity to join a team of highly competent automation and robotics engineers and specialists impacting the way...