- Manage upstream processing operations, including cell culture, filtration, and sterilization.
- Oversee downstream processing activities such as purification and concentration of biopharmaceuticals.
- Ensure compliance with cGMP regulations and maintain accurate records of production batches.
- Collaborate with cross-functional teams to optimize process efficiency and reduce costs.
- Develop and implement strategies to enhance product quality and yield.
- Monitor and control processes to prevent contamination or defects.
- Experience in microbial processing, downstream processing, mammalian cell culture, and upstream processing.
- Solid understanding of downstream processing techniques including filtration, centrifugation, and chromatography.
- Experience working in a regulated environment (cGMP).
- Ability to work collaboratively with cross-functional teams.
- Strong problem-solving skills and attention to detail.
- Familiarity with quality control measures and regulatory requirements.