QC Bioassay Principal Scientist

Job title:

QC Bioassay Principal Scientist

Company

AGC Biologics

Job description

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 your every day will be involved in multiple different tasks of varying complexity? QC Bioassay is looking for a Principal Scientist to be part of our Scientist team.The QC 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, ELISA & 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.Role & Responsibilities:As Principal Scientist you will join a team of 8 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 MSc with 3 – 6 years industry experience preferable from Quality Control or an Analytical Development department or Ph.D. degree in life science with 3 years of relevant experience. 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
• Documented experience from working in a GMP environment and knowledge of relevant EU and US guidelines
• Quality and structured mindset and experience in writing and reviewing GMP documentation, including CR-cases, CAPAs, and deviations
• Documented experience in preparing and optimizing procedures (SOPs, TEQs, etc.) to ensure continuous compliance with GMP
• A strong analytical mindset and problem solving skills
• Structured and detailed oriented but also a strong decision maker with ‘can-do’ attitude
• Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
• The ability to handle multiple tasks simultaneously in a busy environment
• Able to quickly obtain the overview of multiple tasks in challenged situations, can prioritize and make quick and qualified decisions
• Fluency in English is a requirement as English is our corporate language

Your Application:
For further information regarding the position, please contact QC Bioassay Manager, Agata Page, 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.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 and give us a quick Like on !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.

Expected salary

Location

København

Job date

Sun, 11 May 2025 06:12:30 GMT

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