Senior Biomanufacturing Specialist

3 weeks ago


New York, New York, United States Global Life Science Hub Full time
Job Opportunity

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.
Requirements:
  • 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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