Job Description

Job Description

Job Description

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.

This position requires great attention to detail, ability to work in a team environment and a keen interest in optimisation of processes. Scientists will be responsible for adhering to all Quality Management System procedures, safety policies, and relevant parts of cGMP.

Responsibilities:

• 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
• Attend and participate in relevant meetings, training, and development sessions
• Use, maintain and respect company equipment in accordance with the company’s SOPs and health & safety guidelines
• Train and mentor junior staff in downstream processing techniques and GMP practices
• Undertake any other appropriate roles and responsibilities that reasonably fall within the role holder’s skills and experience as requested

Experience/Qualifications:

• 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

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