Downstream Manufacturing Scientist - Remote

Overview

The role will involve performing downstream manufacturing to assure that the process is robust, scalable, and able to be performed in the manufacturing facility – as well as the accompanying documentation. The successful candidate will be familiar with cGMP regulations and technology transfer tasks and work out of the brand-new state-of-the-art facility in New Jersey, USA.

In Short

• Perform as a key member of the Downstream Manufacturing team, liaising with Process development and QA teams
• Design and optimize downstream processing steps, including DNA purification techniques such chromatography, tangential flow filtration and formulation
• Wide experience using AKTA systems, TFF system and deep understanding of DSP processes from a technical point of view
• Stay up to date with current technologies and literature as well as evaluating these new technologies/processes for implementation
• Provide hands-on supporting during manufacturing campaigns, including troubleshooting and resolving production issues
• Assist with tech transfer activities from the Process development department to the cGMP manufacturing facility
• Generate documentation, such as reports/experimental write-ups, that support the validation of processes and during the production’s campaigns
• Execute and deliver projects to a high standard and in accordance with project validation plans
• Analyse data from experiments, interpret results and implement processes
• Record experimental methods and results to a high standard and in-line with company guidelines, maintaining QMS documentation as necessary

Requirements

• MSc in Biochemical engineering (or similar) or BSc in biological sciences, or a related discipline with relevant industry experience (2+ Years)
• Experience of working in downstream processing in controlled environments employing quality standards (e.g., ISO, cGMP, cGLP, cGCP)
• Experience with Chromatographic process development using AKTA systems
• Experience with scale up and/or tech transfer of chromatographic processes would be desirable
• Experience with TFF systems
• Experience of experimental planning, experimental validation and report writing
• Experience in analysis of chromatographic data and understanding the implications of certain product impurities
• Familiarity with regulatory requirements for biopharmaceutical manufacturing
• DoE experience using software packages such as JMP would be desirable but not essential
• A creative and open mindset to tackle novel challenges
• Excellent team working and communication skills
• Excellent record keeping skills

Benefits

• Opportunity to work in a state-of-the-art facility
• Collaborative team environment
• Professional development opportunities
• Hands-on experience in biopharmaceutical manufacturing
• Exposure to cutting-edge technologies