Senior Scientist, Analytical Method Development

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

We are seeking a highly skilled Senior Scientist specializing in the characterization and analysis of protein-based biotherapeutics. The ideal candidate will have a strong passion for analytical characterization, utilizing techniques such as LC-MS, HPLC, and electrophoretic-based assays. This role is part of the Characterization & HPLC team within the Analytical Method Development (AMD) Department at AGC Biologics A/S, located at our Copenhagen site.

About the Department
The Analytical Method Development (AMD) Department consists of 26 dedicated and highly skilled scientists and technicians divided into two sub-teams: Characterization & HPLC and Bioassay. The department’s key responsibilities include:

• Implementation, transfer, and development of analytical procedures.

• Transfer of analytical methods to QC for validation.

• Providing analytical support to early-stage and late-stage process development teams.

• Characterization of biotherapeutic products and drug intermediates.

• Routine testing of characterization assays.

Projects span from early pre-clinical development through all clinical phases to commercial supply. AMD also contributes to cross-functional project groups and implements new analytical technologies and techniques. The department collaborates closely with counterparts at AGC Biologics’ facilities in Seattle (USA), Boulder (USA), Heidelberg (Germany), and Chiba (Japan).

The department fosters an informal and collaborative work environment, with a professional and flexible approach to work. We promise an exciting and diverse role with ample opportunities for professional growth.

About the Team
As a Scientist in the Characterization & HPLC team, you will develop a variety of analytical methods, including intact mass analysis, peptide mapping, glycan analysis, and other chromatographic and electrophoretic techniques. Your work will support a wide range of protein-based drug products, ensuring high-quality outcomes for our customers and enabling rapid market access. You will collaborate with a team of 9 scientists and 7 technicians and work closely with multiple stakeholders, including process development teams, project managers, and QC teams.

About the Role
This role offers the opportunity to work with diverse drug products in different clinical stages and to apply your expertise in a cross-functional, interactive environment.

Your Primary Tasks Will Include...

• Evaluating methods received from clients prior to their implementation at AGC.

• Transferring, developing, and implementing analytical methods for challenging biopharmaceuticals, including method documentation.

• Performing pre-validations to ensure methods are suitable for QC use.

• Processing and reviewing analytical routine testing for biopharmaceutical characterization.

• Troubleshooting analytical methods and instruments.

• Representing AMD in cross-functional project teams.

• Providing verbal and written reports to clients.

Your Qualifications....

• Advanced education in Protein Chemistry, Biochemistry, Biochemical or Chemical Engineering, or a related field (MSc or PhD preferred).

• Preferably 4 years of experience in analytics within the biotech industry.

• Strong practical experience with LC-MS methodologies for proteins.

• Experience in handling and analyzing biopharmaceuticals.

• Preferably theoretical and hands-on knowledge of electrophoretic and HPLC-based methods, e.g., iCE, CE-SDS, SEC, IEX, RP.

• Preferable understanding of sub-visible particle analysis (e.g., HIAC, MFI).

• Familiarity with biopharmaceutical manufacturing and regulatory requirements.

• Experience with analytical instrumentation such as HPLC, electrophoretic systems, and LC-MS systems.

• Ability to work independently in a dynamic environment.

• Strong interpersonal and communication skills.

• Excellent English communication skills, both written and verbal.

Application

• To apply, please submit your CV. We encourage you to apply even if you do not meet every requirement.

• If we see a potential match, one of our recruiters will contact you to discuss your application.

• For further information regarding the position, please contact Esben Trabjerg, Manager in Analytical Method Development, at etrabjerg@agcbio.com.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.