Scientist III/IV: DSP Manufacturing

4basebio is an innovative gene synthesis company with the ambition to provide high quality, synthetic DNA for use in gene therapy and vaccine platforms. We are expanding our teams at our premises just North of Cambridge, UK, to continue supporting the GMP production of our DNA products for use as a starting material in mRNA and viral vector production as well as an API for use in drug products.

We are seeking for a highly skilled and motivated Downstream Processing Manufacturing Scientist to join our team in a Good Manufacturing Practices (GMP) environment. The ideal candidate will have a strong background in bioprocessing, particularly in downstream operations for biopharmaceuticals including purification and formulation process.

The role will involve performing downstream process development experiments 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 and GDP regulations and technology transfer tasks.

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

Person Specification:

• 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
• Must have right to work in the UK

What we can offer:

Competitive salary + comprehensive benefits package

If you are interested in joining the 4basebio team, please forward your CV to HR@4basebio.com

This role is located in Over, North of Cambridge

No agencies please.

Due to the high number of applicants, if you do not hear back from us within six weeks, we thank you for your interest, but please assume you have not been selected for interview on this occasion.