Senior Scientist, MSAT

AGC Biologics A/S; København; On-site; DKK 800,000 - 1,050,000; Full time

Job summary

AGC Biologics, a global CDMO, seeks a Senior Scientist to lead technology transfer, validation, and manufacturing support within MSAT for late-stage and commercial biopharmaceutical projects. You will own projects with strong collaboration across Manufacturing, Quality, Regulatory, Project Management, and customers to ensure robust GMP processes.

You will analyze data, apply risk-based science, and contribute to continuous improvement while working in a GMP manufacturing environment.

Qualifications

• MSc in Biochemistry, Chemistry, Biology, Bioprocess Engineering or related field with 6+ years industry experience, or PhD with 4+ years.
• Strong experience in biopharmaceutical manufacturing and understanding of upstream/downstream processing.
• GMP documentation experience and regulatory familiarity.
• Experience with technology transfer, PPQ, risk assessments, process characterization, and manufacturing support.

Responsibilities

• Technology transfer from customers to manufacturing.
• Process mapping and facility fit assessments.
• Validation activities and PPQ preparation.
• Technical support before, during, and after manufacturing campaigns.

Skills

Bioprocessing

GMP knowledge

Project management

Stakeholder management

Education

MSc in Biochemistry

PhD in related field

Tools

ICH Q7A/21 CFR Part 211

Job description

Make an impact on commercial biopharmaceutical manufacturing At AGC Biologics, your scientific expertise can directly contribute to bringing life‑changing medicines to patients worldwide.

As a Senior Scientist in our Manufacturing Science & Technology (MSAT) organization, you will play a key role in ensuring that complex biopharmaceutical processes are successfully transferred, validated, and supported in commercial manufacturing.

This is a role for someone who enjoys working where science meets real‑world manufacturing. You will take ownership of complex technical challenges, work closely with Manufacturing, Quality, Regulatory, Project Management, and customers, and use data and scientific insight to make processes more robust and continuously improve how we manufacture.

A pivotal role in late-stage MSAT

You will join our Late Stage MSAT team, supporting commercial and late‑stage biopharmaceutical projects from technology transfer through process validation and manufacturing support. As a Senior Scientist, you will have significant ownership and visibility across projects. You will act as a project and/or process owner and help turn scientific knowledge into practical solutions that work in a GMP manufacturing environment.

Your work will include technology transfer from customers into manufacturing, process mapping and facility fit assessments, validation activities, PPQ preparation, and technical support before, during, and after manufacturing campaigns. You will also analyze process and manufacturing data and use science‑ and risk‑based approaches to solve complex technical challenges.

A key part of the role is working across functions and bringing different perspectives together. You will collaborate closely with Manufacturing, Quality, Regulatory, Project Management, and client‑facing teams, while also representing MSAT in customer meetings, audits, regulatory inspections, and cross‑functional project teams. You will also have the opportunity to act as a subject matter expert in areas such as fermentation, harvest, chromatography, filtration, mixing and hold‑time validation, risk assessments, and PPQ.

Where science, ownership and collaboration come together

You will become part of a compact team of experienced scientists with strong expertise in bioprocessing, technology transfer, and process validation. The team operates with a high level of ownership, and several team members are SMEs within their respective areas. That means you will have experienced colleagues to spar with, while also being trusted to take responsibility for your own projects and technical decisions.

The role offers broad exposure across the organization and the opportunity to influence both individual projects and how MSAT works more broadly. You will also contribute to continuous improvement of manufacturing processes, procedures, and MSAT practices – so your impact extends beyond the individual project you are working on.

What you bring to the role

• An MSc in Biochemistry, Chemistry, Biology, Bioprocess Engineering, or a related discipline and 6+ years of relevant industry experience, or a PhD in a related scientific or engineering discipline and 4+ years of relevant industry experience.
• Strong experience with biopharmaceutical manufacturing and a solid understanding of upstream and/or downstream processing, particularly mammalian expression systems.
• Practical GMP experience, including familiarity with relevant regulations and guidelines such as ICHQ7A and21CFR Part211.
• Experience with technology transfer, process validation, PPQ, risk assessments, process characterization, and/or manufacturing process support.
• Experience authoring, reviewing, and approving GMP documentation, combined with the ability to apply scientific and risk‑based thinking to complex problems.
• The ability to provide technical leadership and coordinate activities across Manufacturing and other GMP functions, while managing multiple projects and deliverables.
• Strong communication and stakeholder‑management skills, including the ability to work effectively with customers and internal stakeholders.
• Excellent verbal and written English and the ability to communicate complex technical topics clearly to different audiences.
• You should also be comfortable working independently, making sound technical decisions, and taking ownership.
• A proactive, solution‑oriented approach and a genuine interest in continuous improvement will be important in this role.

Your opportunity at AGC Biologics

This is an opportunity to work with complex biopharmaceutical processes in an environment where your scientific expertise has a direct connection to commercial manufacturing and, ultimately, patients. You will gain broad cross‑functional exposure, work with experienced MSAT colleagues and international customers, and have the autonomy to influence how technical challenges are solved. At the same time, you will be part of a team where knowledge sharing and collaboration are essential to getting the job done.

Location

We can only consider candidates currently based in Denmark or the Greater Malmö area, as relocation support is not available for this position.

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!