Downstream Scientist, Manufacturing Product Support
AGC Biologics
København
Permanent
Fuldtid
20 dage siden
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.Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be for drugs ranging from development to clinical and commercial production. Right now, you have the opportunity to join the Manufacturing Product Support department as a Downstream scientist. This position requires technical problem-solving, process understanding and inter-departmental collaboration.The team owns the production process of the products produced in AGC Biologics. This means that the team all together are responsible for delivery of project specific batch documentation, support the shopfloor during critical process steps and ensuring batch review and handling of deviations. The team has in depth knowledge of the product specific requirements.RESPONSIBILITIES:· Accountable for creating Master Production Records and initial production plans· Responsible for reviewing Master Production Record· Responsible for project specific training of technicians· On call/shopfloor scientist to ensure on the line support during critical process steps· Responsible for facilitating solutions on how to proceed during break-down during batch execution· Responsible for production support and participating during critical process steps· Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation) as well as other quality documents.· Establish and maintain procedures to ensure compliance.Other· Customer meeting representative.· Audits and inspection support.· Responsible for capturing learnings and implementing continues improvements to process.· Knowledge about requirement for relevant products.EDUCATION AND EXPERIENCE:The ideal candidate holds an Academic degree within Life Science and have previously been working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:· Masters or Bachelors Degree in natural or life science related fields· Knowledge of downstream processes.· Preferably have experience writing, reviewing and approving GMP documentation.· Preferably experience with operations of single-use technologies and aseptic processing.· Preferably experience in clinical/commercial GMP manufacturing.· Self-motivated, organized and proactive.· Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Validation, Engineering, QA, QC, etc.).· Experience working with multiple projects simultaneously.· Demonstrated experience leading troubleshooting efforts.· Strong communication skills necessary to interact with internal and external stakeholders.· Strong presentation skills.At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.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.
