Senior Scientist, Quality Assurance

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.

The QA Operations is expanding and is looking for a QA Scientist to assist with quality assurance of biotechnological production.

QA Operations:
QA Operations consists of two sub teams with the main responsibility of quality assurance of manufacturing activities and batch release of microbial manufacturing of drug substances (API) and cell banks. AGC Biologics is a CDMO and covering international pharma customers. We manufacture a big range of drug substances from clinical to commercial.

The department has an open communication with a focus on a high level of professionalism. We are open-minded and have a high service level for our colleagues in the rest of the AGC Biologics organization - and not least for our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration. We actively work within our field of understanding- and interpreting legislation to ensure manufacturing is in compliance with current standards for GMP production, i.e., EU GMP, 21 CFR and ICH guidelines. Continuously we improve our standards within quality- and manufacturing processes, innovate with modern technology and our common value chain with internal stakeholders.

Role and responsibilities:
The QA Scientist provides customer service, with the highest integrity, focused on quality and compliance with partnership with AGC Biologics. The responsibilities include:

• Ensure resolution of significant quality issues with the client through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patient’s safety
• Responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: Batch production records (BPR), Change controls, Deviations, CAPAs, DS specifications, Master Production Records and Risk Assessments
• Support the generation of new, as well as improvement of, existing department SOPs
• Support delivery of AGC projects
• Work with management to resolve project issues and resource constraints within the team
• Support client audits as necessary
• Assist with negotiation terms of Quality agreements with the client as required
• Liaise with the internal and external stakeholders to resolve and clarify any point of issue
• Assist with the generation of APQR (Annual Product Quality Review)

Your profile and experience:
It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. Relevant experience for this role includes:

• You have >2 years of experience with Quality Assurance or >5 years relevant GMP experience.
• A science-based degree or equivalent.
• Substantial experience working in or directly supporting manufacturing within a drug substance/product manufacturing site.
• Previous biopharma experience is preferred.
• Strong working knowledge of the principles and guidelines for GMP.
• Strong decision making and ‘can do’ attitude.
• Excellent written and verbal communication skills to internal and external stakeholders.
• Ability to work in a fast paced, matrix environment essential.
• Capable of working to deadlines and prioritizing multiple tasks.
• Flexibility to meet the changing needs and priorities of the business.

AGC has international customers, and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.

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.
Location: Copenhagen Site