Scientist, Quality Control QC

at  AGC Biologics

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.
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, Cell-based assay group 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 in QC Bioassay which is one out of five departments in our QC Organization. In QC Bioassay we are in total 45 employees, both scientists and technicians, divided into four groups - Bioassay Cell & Reference Material were the position is available, Bioassay Scientists, Bioassay Technicians, and General Analytics. In QC Bioassay we perform a broad range of compendial methods, bioassays (e.g., ELISA’s, protein concentration, 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.
Roles and Responsibilities
As Scientist you will be part of a team of two Scientists and report to the Manager of QC Bioassay Cell and Reference material.
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 associated to cell-based assays, 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
• Support laboratory technicians on daily basis
• Responsible for method validations according to current ICH guidelines
• Participate in troubleshooting and scientific support
• 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
• Key player during regulatory inspections and customer audits

The ideal candidate holds a M.SC. or Ph.D. degree in 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 cell-based assays 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

Application
For further information regarding the position, please contact Manager Anne Lykkegaard Widlund, QC Bioassay Cell and Reference Material, by phone 27602154 or at
awidlund@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.
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
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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

• Review and approval of analytical results
• Support laboratory technicians on daily basis
• Responsible for method validations according to current ICH guidelines
• Participate in troubleshooting and scientific support
• 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
• Key player during regulatory inspections and customer audit