Senior Scientist, MSAT

AGC Biologics; København; On-site; DKK 750,000 - 1,100,000; Full time

Job summary

AGC Biologics seeks a Senior Scientist to lead late-stage MSAT efforts, overseeing technology transfer, process validation, PPQ, and manufacturing support for commercial biopharmaceutical projects. You will drive data-driven optimization across cross-functional teams and customer collaborations.

You will work in a GMP environment, applying risk-based thinking to solve complex technical challenges, with broad exposure to regulatory interactions and project leadership across global sites.

Qualifications

• MSc with 6+ years of industry experience or PhD with 4+ years in the field.
• Strong experience with upstream and/or downstream biopharmaceutical processing, esp. mammalian expression systems.
• GMP experience with ICH Q7A and 21 CFR Part 211.

Responsibilities

• Lead technology transfer from customers into manufacturing and support PPQ activities.
• Perform process validation, risk assessments, and process characterization across campaigns.
• Analyze manufacturing data using scientific insight to improve robustness.
• Coordinate activities across Manufacturing and GMP functions; manage multiple projects.
• Represent MSAT in customer meetings, audits, and regulatory interactions.

Skills

Biopharma manufacturing

Technology transfer

PPQ

Process validation

Risk assessments

GMP documentation

Stakeholder management

English communication

Education

MSc in Biochemistry/ Chemistry/ Biology/ Bioprocess Eng or related

PhD in related scientific or engineering discipline

Job description

Make an impact on commercial biopharmaceutical manufacturing

At AGC Biologics, your scientific expertise can directly contribute to bringing life-saving 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

You have a strong scientific background and several years of experience working with biopharmaceutical manufacturing in a GMP-regulated environment. You are comfortable moving between scientific detail and the broader project picture, and you enjoy taking ownership of complex technical challenges.

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.

We are looking for someone with:

• 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 ICH Q7A and 21 CFR Part 211.
• 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.

Location:

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

The recruitment process will include:

• An initial screening call with People & Culture
• An interview with the Hiring Manager
• A final interview, including a cognitive assessment and personality assessment

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.