Manufacturing Associate III

4 weeks ago

Piscataway, United States Global Life Science Hub Full time
Job DescriptionJob Description

Downstream Manufacturing Associate

We are recruiting a Downstream Manufacturing Associate for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. This position involves handling purification volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment. Proficiency in operating AKTA purification skids, tangential flow filtration (TFF), and familiarity with batch records and technical documents is essential.

Essential Duties & Responsibilities:

  • Execute downstream processes at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
  • Operate and maintain downstream equipment, including AKTA skids and TFF systems.
  • Perform in-process testing and data collection to ensure product quality and process consistency.
  • Assist in preparing and reviewing quality management documents, including deviation reports, change control, and investigation reports.
  • Collaborate with cross-functional teams to ensure the successful execution of engineering and clinical batches.
  • Support process optimization efforts and implement improvements to enhance efficiency and product yield.
  • Ensure compliance with GMP and safety regulations, including maintaining a clean and safe work environment.
  • Assist in troubleshooting process-related issues and performing corrective actions as needed.
  • Participate in investigations and corrective actions for deviations or process failures.
  • Perform other duties as assigned and comply with all company policies and standards.

Requirements:

Education:

  • Bachelor’s degree in chemical, biological, or biochemical sciences.
  • 2-3 years of related experience in downstream processing within the biopharmaceutical industry.

Experience:

  • Experience working in a GMP-compliant environment.
  • Hands-on experience with AKTA purification systems and TFF.
  • Familiarity with batch manufacturing and purification processes for recombinant proteins.

Special Skills:

  • Strong attention to detail and ability to follow protocols accurately.
  • Effective communication and documentation skills.
  • Ability to work collaboratively within a team and adapt to a fast-paced environment.
  • Proficiency in basic computer applications, including Word and Excel.

Work Environment & Physical Demands:

  • Ability to work flexible hours, including weekends or evenings, as required.
  • Capability to work under pressure and meet production deadlines.
  • Some lifting and manual handling of equipment may be required.

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