Senior Scientist, Late Stage Upstream Process Development
2 weeks ago
Apply locations: Copenhagen, Denmark
Time type: Full time
Posted on: Posted 25 Days Ago
Time left to apply: End Date: December 8, 2024 (3 days left to apply)
Job requisition id: JR101067
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.
Are you up for the challenge?
- To apply, please submit your CV. We encourage you to apply even if you do not meet every requirement.
- If we see a potential match, one of our recruiters will contact you to discuss your application.
- If both sides remain positive after this discussion, we will proceed to the assessment stage to evaluate the key skills required for the job.
- For further information, please contact: Tamanna Nagraik, Manager in Late-Stage Process Development at
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.
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