Biopharmaceutical Project Coordinator
2 weeks ago
Our mission at AGC Biologics is to bring hope to life by enabling life-changing therapies for patients worldwide. We strive to create a healthier and happier tomorrow by working side-by-side with our customers to improve patients' lives through new biopharmaceuticals.
As a QC Coordinator, you will play a crucial role in leading and participating in the coordination and planning of analytical QC activities, supporting clinical and commercial manufacturing for our customers globally. You will thrive in an international environment where teamwork and collaboration are paramount.
The Department
QC Chemistry is one of five departments in the QC area, 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. We have a close collaboration within the QC area and with departments across the organization, as well as with external customers and vendors.
Roles and Responsibilities
As a QC Coordinator, you will represent QC Chemistry in customer project teams and internal AGC QC analytical teams. You will have expertise in analytical chemistry (e.g., HPLC, CE, iCE) and general knowledge of analytical QC procedures, as well as basic project management skills or interest.
You will be responsible for maintaining knowledge and overview of QC project milestones and batch release schedules, coordinating and ensuring the timeliness of analytic method validations in collaboration with QC Subject Matter Experts, and being a specification owner, including establishment and update of specifications.
Your Profile and Job Contents
The ideal candidate holds a MSc in Chemistry, Biochemistry, or a relevant area with 2-6 years of relevant experience or a PhD with 3 years of relevant job experience. You should have the ability to represent QC in projects, project core teams, and customer meetings, be a one-point-of-entry into QC-related matters, and lead cross-QC analytical project teams.
You will also be responsible for maintaining knowledge about commercial GMP production and/or production for late-stage clinical trials and production of biotechnological products and APIs, participating in regulatory inspections, and being an advisor for management on QC strategic matters.
Our Culture
At AGC Biologics, our culture is defined by six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. Our core values stem from our team members and are embedded into our DNA, providing a common language and understanding of how we achieve our purpose of bringing hope to life for patients worldwide.
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