Senior Scientist, Upstream, Late-Stage Process Development

AGC Biologics A/S; København; On-site; DKK 850,000 - 1,100,000; Full time

Benefits offered by this job

Mentoring arrangement

Canteen arrangement

Employee Club

Employee discount opportunities

Job summary

AGC Biologics is seeking a Senior Scientist to lead upstream late-stage development activities, focusing on process characterization, down-scale model qualification, and data analysis. You will guide studies from design to reporting, act as SME for clients and internal stakeholders, and drive practical next steps based on scientific findings.

Responsibilities include planning PC studies, designing DSMQ, applying DoE and JMP, contributing to FMECA and risk assessments, supporting LIVCA, WCB,

Qualifications

• Bachelor's/Master's/PhD in biotech, biochemical engineering, or related field.
• At least five years' industry experience with a Master's or two years with a PhD.
• Solid experience with mammalian cell culture, bioreactor operations and scale-up.
• Experience with late-stage process development, including characterization, scale-down models or tech transfer.
• Design studies, apply statistics, interpret complex data, and communicate conclusions.
• Experience with process risk assessments and scientific reporting.
• Fluent in written and spoken English.

Responsibilities

• Plan and lead process characterization (PC) studies with data evaluation and reporting.
• Design and evaluate down-scale model qualification (DSMQ) studies for representativeness.
• Apply statistical methods, including DoE, and tools such as JMP to support conclusions.
• Contribute to FMECA and other risk assessments to identify critical parameters.
• Support late-stage development activities: LIVCA, WCB, scale-up and tech transfer.
• Provide scientific guidance to lab staff and communicate findings to clients.
• Contribute to development reports, technology transfer docs and regulatory submissions.

Skills

Mammalian upstream processes

Bioreactor operations

Scale-up

Design of Experiments (DoE)

JMP

Statistical analysis

Regulatory documentation

Client communication

Education

Biotechnology / Biochemical Engineering degree

Tools

DSMQ

FMECA

AMBR250

Process modelling

DSMQ

JMP

Job description

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.
• Contributing 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 needed. 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.

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. AGC Biologics is Your Friendly CDMO Expert - dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world's most innovative pharmaceutical companies to develop and manufacture their life-changing drug products. If you’re motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!