Senior Analytical Project Manager
12 hours ago
About Us
">At AGC Biologics, we're driven by a shared purpose: to bring hope to life by enabling life-changing therapies for patients worldwide. As a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), we work side-by-side with our clients and partners to deliver 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 Team
">We're a collaborative team of over 2,500 employees worldwide, united by our commitment to continuous innovation and technical creativity. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in key locations. We foster a friendly, collaborative culture that values personal initiative and professional achievement.
">Job Description
">We're seeking an experienced Senior Analytical Project Manager or QC Chemistry Expert to join our QC Chemistry department. As a key member of our team, you will represent our organization in Customer project teams and internal analytical teams. Your expertise in analytical chemistry and project management skills will drive the coordination and overall timeliness of analytic method validations in collaboration with Subject Matter Experts.
">Your Role
">As a Senior Analytical Project Manager or QC Chemistry Expert, your responsibilities will include:
">- ">
- Representing our organization in Customer project teams and internal analytical teams">
- Leading cross-QC analytical project teams">
- Maintaining knowledge and overview of QC Project milestones and Batch release schedules">
- Responsible for coordination and overall timeliness of analytic method validations">
- Specification ownership, including establishment and update of Specifications">
- Keeping overview and driving the in-house transfer of analytical methods from Analytical Development to QC">
- Relating building and communication inside and outside AGC Biologics">
- Writing and reviewing GMP documentation, including CR-cases, CAPAs, and deviations, CoAs, analytical set-ups">
- Upholding knowledge about commercial GMP production and/or production for late-stage clinical trials and production of biotechnological products and APIs">
- Participating in Regulatory inspections, e.g. DMA, FDA, and Customer audits (internal and external audits)">
- Advising Management on QC strategic matters">
- Flluency in written and spoken English">
Your Profile
">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. You have expertise in analytical chemistry, general knowledge of analytical QC procedures, as well as basal project management skills or interest.
">About AGC Biologics
">AGC Biologics is committed to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. 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 our website.
">Contact Information
">Please find this job at our company's career page.
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