Senior Scientist, Upstream, Late-Stage Process Development

AGC Biologics, Inc.; København, Søborg; Remote; DKK 635,000 - 972,000; Full time

Benefits offered by this job

Canteen arrangement

Employee Club

Job summary

AGC Biologics in Søborg, near Copenhagen, seeks a Senior Scientist to lead upstream late-stage development with emphasis on process characterization, down-scale model qualification, and data-driven recommendations for clinical and commercial manufacturing.

You will design studies, interpret data, and report findings as a subject matter expert, mentoring technicians and collaborating across functions to ensure robust, scalable mammalian culture processes. Proficiency with JMP/DoE is advantageous.

Qualifications

• Experience with mammalian upstream processes and scale-up.
• Strong data interpretation and scientific reporting skills.
• Experience in late-stage development and technology transfer is a plus.

Responsibilities

• Plan and lead upstream late-stage development activities with focus on characterization and model qualification.
• Apply DoE and statistical methods to support data-driven conclusions and risk assessments.
• Provide scientific guidance to clients and internal teams; prepare technical documentation and reports.

Skills

Mammalian cell culture

Process characterization

Statistics & DoE

Scale-up & tech transfer

Data interpretation & reporting

Education

Bachelor's/Master's/PhD in biotech or biochemical engineering

Tools

JMP

DoE

AMBR250

DSMQ

FMECA

Job description

Senior Scientist, Upstream, Late-Stage Process DevelopmentWe use cookies to make the safest and most effective website possible.# AGC Biologics## Senior Scientist, Upstream, Late-Stage Process DevelopmentApply: Copenhagen, Denmark: Full time: Posted 2 Days Ago: End Date: December 6, 2026 (23 days left to apply): JR103242**Are you an experienced upstream scientist who enjoys solving complex process challenges and turning scientific data into clear recommendations? Do you enjoy leading late-stage development studies and using your expertise to help clients move their processes towards clinical and commercial manufacturing?** At AGC Biologics in Søborg, we are looking for a Senior Scientist to join our Late-Stage Process Development team.You will join a multidisciplinary team of six scientists and eight technicians working across upstream, downstream, and analytical disciplines. Together, we develop and characterize robust mammalian cell culture processes supporting clinical and commercial manufacturing. **About the Job**As a Senior Scientist, you will lead upstream late-stage development activities, with a particular focus on process characterization, down-scale model qualification, and scientific data analysis. You will be responsible for your assigned scientific activities, from study design and data interpretation to technical recommendations and reporting. As a subject matter expert (SME), you will also serve as a key scientific contact for clients and internal stakeholders, helping explain process performance, address technical challenges, and recommend practical next steps. **Your main responsibilities will include:*** Planning and leading process characterization (PC) studies, including experimental design, data evaluation, and preparation of PC work reports.* Designing and evaluating down-scale model qualification (DSMQ) studies to demonstrate representativeness of manufacturing-scale processes.* Applying statistical methods, including Design of Experiments (DoE), and tools such as JMP to support data-driven scientific conclusions.* Contributing to FMECA and other process risk assessments to identify critical process parameters and support control strategy development.* Supporting late-stage development activities, including Limit of In Vitro Cell Age (LIVCA) studies, Working Cell Bank (WCB) activities, scale-up, and technology transfer.* Providing scientific guidance to laboratory technicians, collaborating across functions, and communicating technical findings, project status, and recommendations to clients. You will also contribute to technical documentation, including development reports, technology transfer documentation, and relevant regulatory submissions. **Who Are We Looking For?**We are looking for an experienced scientist with strong technical knowledge of mammalian upstream processes and the ability to translate scientific data into practical recommendations. We imagine that you:* Hold a Bachelor's, Master's, or PhD degree in biotechnology, biochemical engineering, or another relevant scientific discipline.* Have at least five years of relevant industry experience with a Master's degree or two years with a PhD, or an equivalent combination of education and experience.* Have solid experience with mammalian cell culture processes, including bioreactor operations and scale-up.* Have experience with late-stage process development, such as process characterization, scale-down models, or technology transfer.* Can design studies, apply statistical methods, interpret complex data, and communicate scientifically sound conclusions.* Have experience with process risk assessments and preparing clear scientific reports and technical documentation.* Communicate effectively with clients and cross-functional colleagues and are fluent in written and spoken English. Experience with JMP, DoE, AMBR250, DSMQ, FMECA, statistical equivalence testing, process modelling, or regulatory submissions will be an advantage. We recognize that candidates may bring different combinations of these skills and do not expect you to have experience with every method or technology listed. You work independently, take responsibility for your commitments, and maintain high standards of scientific quality. You can structure your work and prioritize competing tasks, even when project requirements change.When challenges arise, you approach them calmly and logically, communicate openly about progress and risks, and involve colleagues or your manager when support is need. You are comfortable discussing scientific findings with clients, explaining the rationale behind your recommendations, and working with others to resolve challenges. You value mutual respect, open communication, and learning from colleagues. **What We Offer**At AGC Biologics, you will work on different client projects, helping prepare mammalian upstream processes for clinical and commercial manufacturing. We offer:* The opportunity to lead late-stage upstream development studies and work on different scientific and process challenges.* A multidisciplinary environment where scientific discussions, collaboration, and knowledge sharing are part of everyday work.* A manager who gives you room to plan your work independently, values honest discussions, and is available when you need support.* An initial mentoring arrangement to help you become familiar with our processes, systems, and ways of working.* Access to our canteen arrangement, Employee Club, and employee discount opportunities. **Interested?**If you are motivated by combining scientific expertise, project responsibility, and client collaboration, we would like to hear from you.Please submit your application and CV through our recruitment system. Applications will be reviewed continuously, and we reserve the right to close the job posting once we have found the right candidate. **Expected Start Date: February 1, 2027** **Who We Are** *AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‐changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.*