What are the responsibilities and job description for the Scientist, Quality Control position at AGC Biologics A/S?
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 Microbiology is looking for a Scientist in the Microbiology laboratory team.
The QC Department & QC Microbiology
The Quality Control (QC) department at AGC Biologics in Søborg is comprised of approximately 160 employees organized into five areas: QC Microbiology, QC Bioassay, QC Chemistry, QC Support and QC Planning & Systems. In the QC area, we support the production of new biopharmaceuticals by overseeing raw materials, conducting analytical testing, monitoring the environment in production rooms, planning, and executing stability programs, and validating various analytical methods according to ICH guidelines for clinical phase I to phase III and for commercial use.
The QC Microbiology department consists of two arears: QC Microbiology Laboratory (ML) and QC Environmental Monitoring (EM), which includes 4 EM scientists and 6 ML scientists, in total we are 31 persons in the department.
We are currently seeking a scientist for the QC Microbiology Laboratory area. The primary responsibilities is to evaluate and approve results, generate project related GMP documentation, write deviations and change requests, and continuously optimize procedures (such as SOPs and TEQs) to ensure ongoing compliance with cGMP under a LEAN framework. Furthermore, the scientists are responsible for method validation and addressing microbiological issues related to customer projects and audits.
Working in the QC Microbiology department involves a wide range of tasks and interactions with numerous products and customers. Unlike traditional pharmaceutical companies, the work at AGC is diverse and continuously offers new knowledge and experience. We are seeking an engaged and ambitious scientist, who has some understanding of Microbiology, testing and validation and GMP biopharmaceutical production.
Our contributions are vital to both drug substance production and facility compliance. The QC Microbiology department collaborates closely with Manufacturing, QA, and Development departments, as well as external laboratories, to maintain control throughout all steps of the manufacturing process. We prioritize close collaboration with our customers in everything we do.
Role & Responsibilities
You will be responsible QC Microbiology scientist for the microbiological analyses in the department, where evaluation of results and generation of project related GMP documentation will be a natural part of your daily work. Gathering data for reports, writing deviations and constantly optimizing procedures (SOP’s, TEQ’s etc.), ensure continuous GMP compliance with a LEAN mindset. Further, you will be involved in Validation of microbiological methods for the new projects.
You will be ensuring cGMP compliance and participate in customer audit and regulatory inspection, which, we as leading CDMO, experience a lot. This calls for a strong GMP mindset and experience.
Further, AGC Biologics in Søborg is growing with new facilities for drug substances production. The new facility that soon will be ready, include new QC laboratories, where we are looking forward to moving into this year.
It is pivotal that you have interest in continuous improvement and process optimization.
Your profile
The ideal candidate holds a MSc or PhD degree in Microbiology or other relevant field and have some of the following qualifications:
- Knowledge of microbiology quality control in biopharmaceutical production
- Knowledge of endotoxin testing and method validation
- Validation of microbiological methods
- GMP and biopharmaceuticals production
- Familiar with EMA, FDA, and ICH regulations for biologics
- Enjoy working in close collaboration with your colleagues
- You are structured and responsible with respect for deadlines and quality
- Like to share your knowledge and communicate openly and professionally both internally and with external customers
- Good English communication and ability to effectively communicate with others engaging with customers and colleges of various cultural background
- Lean skills will be an advantage
AGC has international customers and our company language is English. It is therefore vital to be fluent in written and spoken English.
Your Application
We will process the applications as they are received. Therefore, we encourage you to submit your application and CV as soon as possible. Once we find the right candidates, the job posting will close. We look forward to receiving your application today! For further information regarding the position, please contact Susanne Vestergaard, Director, at 45 22 94 29 32.
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.
