Two Senior Scientists, QC Bioassay

We are looking for a two Senior Scientists to be part of our Scientist team within the bigger QC Bioassay area. Are you looking for an exciting job in a fast-growing international CDMO organization producing new biological medicines? Do you enjoy working in a dynamic environment, where you every day will be involved in multiple different tasks of varying complexity?

You will become a part of a dedicated QC Bioassay team

The positions will be placed on QC Bioassay which is one out of five departments in our QC Organization. In QC Bioassay, we are in total 52 employees, both scientists and technicians, divided into five groups - Bioassay Scientists, Bioassay Technicians, Bioassay Cell & ELISA Based Methods, Reference & Critical Materials and General Analytics. We perform a broad range of compendial methods, bioassays (e.g. ELISA, Octet qPCR, and SDS-PAGE), as well as cell-based assays. We are responsible for method validations for early and late stage products, release testing of clinical and commercial batches (DS and DP) as well as testing of stability samples. Finally, but not least we are responsible for supporting the 24/7 operating manufacturing of biopharmaceuticals by testing of in-process stop/go samples.

"These two positions offer you an exciting opportunity to apply your ELISA expertise in a dynamic GMP QC environment, where you will play a key role in validating a wide range of ELISA methods supporting both clinical development and commercial manufacturing!" - Ann-Louise Theis Littau, Manager of this QC Bioassay team

You will be a valued ELISA expert in our team!

As a Senior Scientist you will join a team of 12 colleagues, both scientists and technicians and report to the Manager of QC Bioassay ELISA, Cell-based Assays and Reference Material team. You will be involved in multiple different tasks all related to ensure timely release and stability testing of product (DS/DP) for our customers. You will be responsible for review and approval of results specifically with a focus on our many different ELISA methods, related method validation activities, and compliance activities. Furthermore, you will be involved in coordination and execution of analytical activities in QC Bioassay and across the QC area. An everyday with us will include the follow tasks:

• Review and approval of analytical results
• Responsible for method validations according to current ICH guidelines
• Participate in troubleshooting and scientific support on ELISA methods
• Drive compliance documents related to QC activities
• Collaboration with multiple stakeholders both within QC and cross-functional departments including Analytical Development, Project Managers, and QA
• Ensuring all tasks performed in cGMP compliance

As we continuously support the manufacturing production, the scientist will be included in our on-call team responsible for support on review and approval of results outside normal working hours, but not evening or night, only day time.

Do you recognize yourself as a specialist/SME?

The ideal candidate is a specialist/SME with great ELISA experience. It is an advantage if you bring relevant QC and GMP experience. We will appreciate all the knowledge you bring from a relevant study, being a MSc or PhD, in combination with a minimum of 3 years of industry experience, preferably from QC, Analytical Development or similar. Moreover, we expect you bring some of the following capabilities:

• Experience with ELISA methods and expertise in Cell-based potency assays will as well be an advantage
• A strong analytical mindset and troubleshooting skills
• Structures and detailed oriented but also demonstrate a pragmatic can-do-attitude
• Hands on experience with handling laboratory investigations, deviations and CAPA’s
• Experience with working in a cGMP setting according to EU and US guidelines

Your working style will fit well with us if you thrive working in a dynamic environment and are able to keep the overview of multiple simultaneous tasks also when priorities are frequently changing. We are looking for someone with good communication skills and a service-minded attitude to meet customer requests in a positive and professional way. Fluency in English is a requirement as English is our corporate language.

Your application & our interview process

Send your application no later than May 31. We treat the applications as we receive them and conduct interviews with qualified applicants during the first weeks of June, aiming for a start date August 1. We look forward to hearing from you!

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.  

Global contract development and manufacturing organization (CDMO) for biopharmaceuticals and cell/gene therapies. Based in Seattle, WA.

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