Downstream Manufacturing Specialist
Downstream Manufacturing Associate or Scientist to oversee the purification of 50L to 2000L volumes for engineering, clinical, and commercial batches in a cGMP environment. This role requires advanced technical expertise in downstream processes, including AKTA purification skids (or similar), tangential flow filtration (TFF), and comprehensive knowledge of batch records, protocols, investigations, and technical documentation.
Essential Duties & Responsibilities
- Execute downstream purification processes at various scales (50L to 2000L) within a cGMP environment, including column packing, troubleshooting, and data analysis.
- Provide technical leadership in the development and execution of downstream purification processes.
- Utilize software systems to collect, monitor, and evaluate operational data, making real-time adjustments to downstream processes, instruments, or equipment.
- Ensure the timely and efficient execution of engineering and clinical batches.
- Establish specifications for downstream equipment and improve manufacturing techniques to enhance process efficiency.
- Collaborate with cross-functional teams and external vendors to address technical challenges and maintain downstream production equipment.
- Adhere to and enforce strict GMP and environmental health and safety (EHS) policies in the manufacturing environment.
- Lead investigations and implement corrective actions for downstream process deviations encountered during batch execution.
- Perform additional responsibilities as required, ensuring alignment with company policies and quality standards.
Qualifications & Requirements
- A Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences, with 4–5 years of relevant experience in the biopharmaceutical industry.
- Proven expertise in downstream purification within a cGMP and aseptic manufacturing environment.
- Hands-on experience with AKTA Process skids or equivalent systems, as well as familiarity with single-use manufacturing consumables (e.g., bags, tube sets, columns, and process manifolds).
- Comprehensive knowledge of GMP documentation and the ability to execute engineering and clinical batches.
- Strong troubleshooting and problem-solving skills specific to downstream processes and purification.
