Scientist, QA Manufacturing Support

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 passionate about Quality Assurance, experienced in GMP and interested in supporting the manufacturing operations of an international, growing and fast-paced CDMO like AGC Biologics?

The QA Manufacturing Support team is looking for a Scientist! You will be responsible for quality activities supporting Manufacturing Operations in accordance with procedures and GMP requirements. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.

Your Application

Apply today! We will process the applications as they arrive with interviews during June. Therefore, please submit your CV as soon as possible. Due to the Summer holidays, the hiring team will be unavailable from the 5th of July to the 3rd of August.

The Scientist Role & Responsibilities

• Provide Quality presence in the production area in relation to documents on the line, perform product checks during manufacturing, line clearance, and provide quality support for production enquiries.
• Inform line management of any issues relating to the quality of products or materials.
• Work with manufacturing to drive improvements in GMP compliance across all shifts.
• Support manufacturing during batch review with Good Documentation Practice related queries.
• Perform Quality review and approval of deviations (DEVs), change controls (CRs) and CAPAs.
• Buffer and media MPR review and approval.
• Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs.
• Participate in GEMBA walks of the production area and conduct specific site system audits in accordance with the agreed schedule.
• Shipping and pre-packing approval.
• Manufacturing label management.
• Archiving.
• Weekend and evening shifts as necessary.
  
  

Your Profile

The ideal candidate holds a relevant Master's degree. Further, experience with QA Oversight in the production area is a plus. More relevant experience and characteristics could be:

• Previous biopharma experience is preferred but not a requirement.
• Strong working knowledge of the principles and guidelines for GMP is a plus.
• Strong decision maker and ‘can do’ attitude.
• Excellent written and verbal communication skills to internal and external stakeholders.
• Ability to work in a fast paced, matrix environment is essential.
• Capable of working to deadlines and prioritizing multiple tasks.
• Flexibility to meet changing needs and priorities of the business.
• Experience working in a GMP aseptic manufacturing environment will be a plus.
  
  

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.