Biologics Regulatory Lead

Job Description:The Director of Regulatory Affairs for CMC Biologics will lead the development and execution of regulatory strategies for biologics and rare diseases. This role requires a seasoned leader with extensive experience in regulatory affairs, able to inspire and empower teams to deliver high-quality results.Key Responsibilities:Develop and execute...

Director of Regulatory Affairs for CMC Biologics & Rare Diseases Category: Project Management & Agile Location: Søborg, Capital Region of Denmark, DK Are you an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs? Do you excel in a dynamic environment and want to be part of a rapidly...

At AGC Biologics, our purpose is to bring hope to life by enabling life-changing therapies for patients worldwide. We create a healthier and happier tomorrow by working side by side with our customers to improve patients' lives through new biopharmaceuticals.We are seeking an experienced QA scientist to assist with Quality Assurance of Material Management....

Job Summary:The Director of Regulatory Affairs for CMC Biologics will be responsible for developing and executing regulatory strategies for biologics and rare diseases. This role requires a highly experienced and visionary leader who can inspire and empower teams to deliver high-quality results.Key Challenges:Developing and executing global approval...

Job Description:We are seeking an experienced leader to join our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. As a key member of our leadership team, you will play a pivotal role in shaping the future of RA CMC. Your expertise in drug regulatory affairs will drive excellence in our pipeline and deliver regulatory approvals...

We are AGC Biologics, a leading Contract Development Manufacturing Organization (CDMO) dedicated to delivering high-quality biologics manufacturing services. Our team is comprised of experts in quality assurance, process development, and analytical sciences.We are seeking a skilled QA professional to lead our Material Management team. In this role, you will...

At AGC Biologics, we strive to maintain a positive and proactive work environment that fosters close collaboration between teams. Our company culture emphasizes professionalism, flexibility, and a focus on delivering exceptional results.We are seeking an experienced QA professional to join our Material Management team. In this role, you will be responsible...

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.At AGC Biologics, you will get a unique opportunity working with a variety of state-of-the-art technologies among +40 different nationalities.This opens many doors for personal development and for...

About UsAt AGC Biologics, we foster a collaborative atmosphere characterized by open communication, mutual support, and a flexible approach across all teams.We value personal initiative and professional achievement, offering a highly competitive compensation package and a friendly, collaborative culture that promotes rapid personal and professional...

Job DescriptionWe are seeking a highly skilled Analytical Project Manager to join our QC Chemistry team. The successful candidate will be responsible for leading and participating in coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers worldwide.Key Responsibilities:Representing QC...

Job SummaryWe are looking for a highly motivated and detail-oriented Compliance Engineer to join our team. As a Compliance Engineer, you will play a key role in ensuring that our facilities and processes meet regulatory requirements.About the PositionYou will be part of the Plant Engineering department, responsible for implementing and maintaining quality...

About the Company CultureOur core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.We embody six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork.About the JobAs a senior member of our Material Science team, you will be responsible for leading our...

About the RoleWe are seeking a highly motivated and organized QC Coordinator/Analytical Project manager to join our QC Chemistry team. The successful candidate will be responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from...

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.An exciting and diverse career opportunity awaits you in our Process Transfer...

Avoiding risk and ensuring accuracy in our financial management is crucial for AGC Biologics' success.We need a highly skilled and experienced Head of Accounting and Controlling who can oversee our financial operations and make informed decisions that drive business growth.This role involves leading a team of professionals in the accounting and controlling...

Job SummaryWe are looking for a highly motivated Analytical Stability Expert to join our QC Stability Team. The successful candidate will be responsible for developing and implementing stability protocols and reports, collaborating with stakeholders, and ensuring cGMP compliance.Key Requirements:MSc in Biochemistry, Pharmaceutical Sciences, or a related...

Company OverviewAGC Biologics is 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.

We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest...

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), dedicated to improving life quality by bringing new biopharmaceuticals to market.We deliver deep expertise, dynamic solutions, and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene...

Welcome to AGC Biologics, a global Contract Development Manufacturing Organization (CDMO) providing comprehensive services from DNA to active pharmaceutical ingredient (API). Our company culture is built around collaboration, innovation, and a commitment to excellence.We seek an experienced QA professional to lead our Material Management team. This key role...