Scientist, Manufacturing Specialist
4 weeks ago
We are seeking a talented Scientist to join our Manufacturing Product Support department at AGC Biologics. This is an exciting opportunity for a skilled professional to contribute to the production process of buffers and media for commercial production.
The ideal candidate will have experience working in a cGMP environment and be proficient in technical problem-solving, process understanding, and inter-departmental collaboration. This role requires strong communication skills to interact with internal and external stakeholders.
Key Responsibilities- Master Production Record Management: Create, review, and maintain Master Production Records.
- Production Support: Provide timely and error-free support to the production line.
- On-Call Support: Be available for on-call support during critical process steps.
- Deviation Management: Investigate and close deviations in a timely manner.
- Quality Documents: Prepare and review quality documents as required.
- Compliance and Procedure Development: Ensure compliance with regulatory requirements and develop procedures to maintain compliance.
The ideal candidate will have an academic degree in a life science-related field and relevant experience working in a manufacturing team operating under cGMP. They should possess strong technical knowledge and problem-solving skills, as well as excellent communication and teamwork abilities.
Preferred qualifications include experience with cGMP documentation, single-use technologies, and aseptic processing. The candidate should also be able to work effectively in a fast-paced environment and prioritize tasks to meet deadlines.
About AGC BiologicsAGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. 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.
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