QC Coordinator (Analytical Project Manager), QC Chemistry

at  AGC Biologics

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 motivated by leading and participating in coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers worldwide? Do you thrive in an international environment where teamwork and collaboration are on top of the agenda? Then we might have just the right opportunity for you!
The Department
QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new or marketed biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. QC Chemistry have a close collaboration within the QC area and with departments across the organization as well as AGC Biologics external Customers and external vendors.
Roles and responsibilities
As a QC Coordinator/Analytical Project manager in QC Chemistry it is required that you have expertise in analytical chemistry (e.g. HPLC, CE, iCE) along with general knowledge of analytical QC procedures, as well as basal project management skills or interest.
You will represent QC Chemistry in Customer project teams and in internal AGC QC analytical teams. Since we are in the process of further refining and professionalising the QC Coordinator role in QC, an interest in organisational optimization is seen as an additional advantage.
Your Profile and Job Contents
The ideal candidate holds a MSc within Chemistry, Biochemistry or other relevant area with 2 - 6 years relevant experience or a PhD with 3 years relevant job experience.

The preferred candidate should match the following experience and characteristics or have the capabilities to develop towards the role description:

• Ability to represent QC in Projects, Project Core Teams and Customer meetings
• Be One-point-of-entry into QC related matters
• Leader of cross-QC Analytical project teams
• Experienced with working in cGMP settings according to European and US regulatory guidelines
• Maintain knowledge and overview of QC Project milestones and Batch release schedules
• Responsible for coordination and overall timeliness of analytic method validations in collaboration with QC Subject Matter Experts
• Be Specification owner including establishment and update of Specifications
• Keep overview and drive the in-house transfer of analytical methods from Analytical Development to QC
• Relation building and communication inside and outside AGC Biologics
• Write and review GMP documentation, including CR-cases, CAPAs, and deviations, CoAs, analytical set-ups
• Uphold knowledge about commercial GMP production and/or production for late-stage clinical trials and production of biotechnological products and APIs
• Participate in Regulatory inspections e.g. DMA, FDA and Customer audits (internal and external audits)
• Advisor for Management on QC strategic matters
• Fluent in written and spoken English

It is important to have a self-motivating personality with a pragmatic, solution oriented approach to the daily work, without compromising quality. Furthermore, you thrive in a dynamic environment and enjoy a rapid pace of work where we all work as one team. You bring a positive, can-do attitude and a good sense of humor.
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
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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

• Ability to represent QC in Projects, Project Core Teams and Customer meetings
• Be One-point-of-entry into QC related matters
• Leader of cross-QC Analytical project teams
• Experienced with working in cGMP settings according to European and US regulatory guidelines
• Maintain knowledge and overview of QC Project milestones and Batch release schedules
• Responsible for coordination and overall timeliness of analytic method validations in collaboration with QC Subject Matter Experts
• Be Specification owner including establishment and update of Specifications
• Keep overview and drive the in-house transfer of analytical methods from Analytical Development to QC
• Relation building and communication inside and outside AGC Biologics
• Write and review GMP documentation, including CR-cases, CAPAs, and deviations, CoAs, analytical set-ups
• Uphold knowledge about commercial GMP production and/or production for late-stage clinical trials and production of biotechnological products and APIs
• Participate in Regulatory inspections e.g. DMA, FDA and Customer audits (internal and external audits)
• Advisor for Management on QC strategic matters
• Fluent in written and spoken Englis