Denmark Job Openings
AGC Biologics
Review & Documentation Scientist
Copenhagen
FULL TIME
October 2, 2024
RESPONSIBILITIES:
-
Responsible for/consulted during MPR creation on process steps to align production flow and GDoc P requirements
After batch execution
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Accountable for timely batch review according to KPI
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Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation) according to KPI
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Responsible for enabling timely batch release
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Responsible for data feedback/status on release process
Other
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Responsible for capturing learnings and align with MPR template owner to continuously improve MPR template
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Responsible for sharing knowledge across project groups
EDUCATION AND EXPERIENCE:
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Master’s Degree in Engineering or Protein Science-related field or similar
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Have experience writing, reviewing and approving GMP documentation.
-
Experience preferably in clinical/commercial GMP manufacturing.
-
Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
- Experienced with operations of single-use technologies and aseptic processing.
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Self-motivated, organized and proactive.
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Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Development, Engineering, QA, QC, etc.).
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Experience working with multiple projects simultaneously.
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Demonstrated experience leading troubleshooting efforts.
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Strong communication skills necessary to interact with internal and external stakeholders.
-
Strong presentation skills.
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 (p DNA), messenger RNA (m RNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with c GMP-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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