Senior Biomanufacturing Specialist
3 weeks ago
Global Life Science Hub is partnering with a leading biopharmaceutical company to fill a critical role in their manufacturing team. The company has achieved significant milestones, including two FDA approvals, and is expanding its operations to meet growing demand.
We are seeking a highly skilled Downstream Manufacturing Specialist to join our client's team. This individual will be responsible for purifying clinical and commercial batches in a cGMP environment, utilizing expertise in AKTA purification skids, TFF, and chromatography column packing.
Key Responsibilities:- Execute downstream processes at multiple scales in a cGMP environment, ensuring compliance with regulatory requirements.
- Provide technical direction in the development and execution of purification processes, collaborating with cross-functional teams.
- Analyze operating data to optimize product quality, instrument performance, and equipment efficiency.
- Ensure timely execution of engineering and clinical batches, maintaining high-quality standards.
- Develop and implement process improvements, working closely with vendors and internal stakeholders.
- Lead investigations and corrective actions for issues arising during batch execution, ensuring compliance with GMP and environmental health and safety policies.
- Bachelor's or Master's degree in a life science field.
- Minimum 3 years of experience in downstream processing, with a focus on aseptic manufacturing.
- Proven expertise in running chromatography systems, packing columns, and TFF operations.
- Familiarity with AKTA process skids and Unicorn software is highly desirable.
- Strong knowledge of GMP documentation and regulatory requirements.
Global Life Science Hub is a specialized recruitment firm, partnering with life science companies to find top talent. If you're interested in this opportunity, please apply below. For more job openings, visit our website.
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