Manufacturing Associate III

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.