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Manufacturing Associate III
2 months ago
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.
