Downstream Process Specialist
4 days ago
We are seeking a highly skilled Downstream Process Specialist to join our Clinical Manufacturing Product Support department. As a key member of our team, you will be responsible for supporting the production process of clinical products, ensuring error-free and timely execution.
This is an exciting opportunity to work with state-of-the-art technologies, collaborate with cross-functional teams, and contribute to the development of innovative biopharmaceuticals.
If you have a strong background in downstream operations, cGMP experience, and excellent problem-solving skills, we encourage you to apply.
- Prior to batch execution: Create Master Production Records (MPRs) and initial production plans, review Master Production Instructions, and train technicians on MPRs.
- Batch execution: Provide on-call support during critical process steps, facilitate solutions for break-downs, and participate in critical process steps.
- After batch execution: Close deviations in a timely manner, conduct root cause investigations, and enable timely batch release.
Key Responsibilities:
- Customer-facing representative for audits and inspections
- Capturing learnings and implementing continuous improvements to processes
- Knowledge about requirements for clinical products
Educational Requirements:
The ideal candidate holds an Academic degree in Biotechnology/Science and has previous experience working in a manufacturing team operating under cGMP, preferably within the pharmaceutical industry.
Required Skills and Qualifications:
- Master's Degree in Life Science, Engineering, or Protein Science-related field
- Experience in downstream operations, preferably in clinical/commercial GMP manufacturing
- Demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations
- Experience writing, reviewing, and approving GMP documentation
- Self-motivated, organized, and proactive
- Ability to coordinate multi-departmental tasks and deliverables
- Experience working with multiple projects simultaneously
- Demonstrated experience leading troubleshooting efforts
- Strong communication skills necessary to interact with internal and external stakeholders
About AGC Biologics
We offer a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. We strive to create an inclusive environment where diversity is valued, and everyone feels welcome and empowered to succeed.
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