QC Bioassay Scientist

Copenhagen, Denmark

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? QC Bioassay is looking for a Scientist to be part of our Scientist team.

AGC Biologics A/S is a global CDMO, where we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. We are working in an international and customer-oriented way to secure fast and reliable manufacturing of medicines to our customers. The department The position is placed on QC Bioassay which is one out of five departments in our QC Organization. In QC Bioassay we are in total 48 employees, both scientists and technicians, divided into four groups - Bioassay Scientists, Bioassay Technicians, Bioassay Cell & Reference Material, and General Analytics. We perform a broad range of compendial methods, bioassays (e.g. ELISA’s, 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. Roles and Responsibilities As Scientist you will join a team of 12 Scientists and report to the Manager of QC Bioassay Scientist team.

In the vacant scientist position 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 from a broad range of methods, 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.

Your Key Responsibilities

• Review and approval of analytical results
• Responsible for method validations according to current ICH guidelines
• Participate in troubleshooting and scientific support on a broad range of bioassay 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

Your Profile The ideal candidate holds a M.SC. or Ph.D. degree life sciences and has preferable experience from the pharmaceutical industry preferable from Quality Control or an Analytical Development department. We expect that you thrive working in a dynamic environment and able to keep the overview of multiple simultaneous tasks also when priorities are frequently changing.

Moreover, we expect you bring some of the following characteristics and capabilities:

• Experience with bioassay methods
• 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
• 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

ApplicationFor further information regarding the position, please contact Interim Manager Agata Page, QC Bioassay, at apage@agcbio.com We treat the applications as we receive, and conduct interviews with qualified candidates. Therefore, please submit your application as soon as possible. When the right candidates are found, the add will close.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.