Process Development Engineer
2 weeks ago
At Infotree Global Solutions, we are seeking a highly skilled Process Development Engineer to join our Drug Substance Technology Engineering team in Thousand Oaks. As a key member of our team, you will provide process engineering support for human therapeutic products in clinical development through commercial production.
Key Responsibilities:
- Transfer upstream (cell culture & harvest) drug substance processes and facilitate process improvements from the laboratory into the manufacturing facility.
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operations.
- Offer process validation support for late stage commercial processes.
- Provide routine process monitoring and troubleshooting.
- Execute data trending and statistical process analysis.
- Support technical direction for process related deviations, CAPAs and change controls.
- Identify and support process related operational excellence opportunities.
Requirements:
- Biotech background/experience, plus cell culture and/or purification experience.
- Strong communication skills, comfortable speaking to a group of 20+ manufacturing associates in presentation.
- GMP experience highly preferred, with a background in dealing with FDA/inspectors/auditors.
Day-to-Day Responsibilities:
- Work on cell-based assay development, assay execution, and data analysis.
- Maintain mammalian cell cultures.
Top 3 Must-Have Skill Sets:
- Upstream experience.
- Strong communication skills.
- GMP experience.
About Us:
Infotree Global Solutions is a leading provider of innovative solutions for the biotech industry. We are committed to delivering high-quality products and services that meet the needs of our customers.
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