Senior Scientist, Upstream, Late-Stage Process Development

AGC Biologics; København; Presencial; DKK 800.000 - 1.100.000; Jornada completa

Descripción de la vacante

AGC Biologics in Søborg is seeking a Senior Scientist to lead upstream late-stage development activities and to drive process characterization, down-scale model qualification, and data analysis.

You will guide studies, interpret complex data, and provide technical recommendations to clients and internal teams, while ensuring scientific rigor and clear documentation.

Formación

• Bachelor's/Master's/PhD in biotechnology, biochemical engineering, or a related scientific discipline.
• At least five years of relevant industry experience with a Master’s or two years with a PhD, or equivalent.
• Experience with mammalian cell culture processes and scale-up; familiarity with late-stage development.

Responsabilidades

• Lead upstream late-stage development activities including process characterization and down-scale model qualification.
• Apply DoE and JMP to support data-driven conclusions.
• Contribute to risk assessments (FMECA) and support control strategy development.
• Support technology transfer, LIVCA, WCB activities, scale-up, and regulatory documentation.
• Communicate findings and recommendations to clients and internal stakeholders.

Conocimientos

Data analysis

Statistical methods

Project leadership

Communication with clients

Educación

Bachelor's/Master's/PhD in biotechnology or related field

Herramientas

JMP

DoE

DSMQ

FMECA

Statistical modelling

Regulatory submissions

Descripción del empleo

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 ment