Senior Scientist, Late Stage Development

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.

For our ambitious, fast-growing team in Copenhagen, we are looking for a Senior Scientist specializing in Late-Stage Upstream Process Development. Working in the Late Stage Process Development team, you will take a leading role in characterizing and optimizing mammalian upstream processes for biologic drug candidates in late-stage development. This role includes driving the transition of processes from early- to late-stage development, providing scientific support in troubleshooting and process improvements, and ensuring regulatory compliance through cross-functional collaboration.

About the department
Our Late Stage Process Development Department plays a crucial role in transitioning processes from clinical scale to commercial manufacturing. The department is composed of three teams focused on process robustness, scalability, characterization, and ensuring regulatory compliance for biologics in advanced development stages.

About the role
We are currently looking for a senior scientist with an upstream background to join one of the teams and work closely with other process development scientists and technicians. Join us as we continue to push the boundaries of science and engineering to bring life-saving therapies to market.

Your primary tasks will be…

• Leading characterization studies for mammalian upstream processes for late-stage biologic drug candidates.
• Driving the transfer of processes from early- to late-stage development.
• Providing scientific support in troubleshooting and improving upstream processes.
• Collaborating cross-functionally with MSAT and quality teams to ensure seamless integration and transfer of processes.
• Authoring and reviewing technical documents, including characterization protocols, reports, and regulatory submissions.
• Acting as a subject matter expert (SME) in client discussions related to upstream processes.

Your qualifications…

• Ideally, a PhD in Cell Biology, Biochemistry, or Biochemical Engineering.
• Expertise in mammalian cell culture, bioreactor operation, and process scale-up from AMBR250 to bench scale.
• Excellent problem-solving skills, scientific creativity, and attention to detail.
• Strong interpersonal and communication skills, with the ability to work collaboratively in a team-oriented environment.
• Fluency in written and verbal English.

It is advantageous if you have…

• Experience presenting scientific results and participating in regulatory meetings or inspections.
• A proven track record in late-stage upstream process development and technology transfer to clinical and/or commercial manufacturing.
• Experience in statistical design of experiments (DoE), process modeling, and data analysis.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC 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. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.