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Downstream Scientist
2 months ago
Job Summary
The Downstream Manufacturing Scientist is a critical role within Medix™ Biopharmaceutical Development team, responsible for the purification of large volumes of clinical and commercial batches in a controlled environment. This position requires extensive technical expertise in mammalian cell-based purification processes, manufacturing, and compliance for regulatory requirements.
Key Responsibilities
- Perform downstream process development and scale-up in a controlled environment, including column packing, process troubleshooting, and data analysis.
- Provide technical direction in the execution and development of the purification process, ensuring compliance with regulatory requirements.
- Utilize data analytics tools to collect and evaluate operating data, making on-line adjustments to products, instruments, or equipment as needed.
- Ensure timely execution of engineering and clinical batches, maintaining high-quality standards.
- Establish operating equipment specifications and improve manufacturing techniques to optimize efficiency and productivity.
- Collaborate with cross-functional teams and external vendors to resolve technical issues and maintain production equipment.
- Adhere to Good Manufacturing Practices (GMP) and environmental health and safety policies, taking the lead in ensuring a safe working environment.
- Coordinate investigations and corrections for issues found during batch execution, ensuring prompt resolution and minimal disruption to production.
Requirements and Qualifications
Education:
- Bachelor's degree in chemical, biological, or biochemical sciences.
- Minimum of 2 years of related experience in the biopharmaceutical industry.
- Previous experience working in a controlled environment, such as GMP and aseptic manufacturing.
- Familiarity with AKTA Process skids or similar equipment and single-use manufacturing consumables.
- Knowledge of GMP documentation and experience executing engineering and clinical batches.
