Be a part of the 4basebio team

The IT Compliance Lead will be responsible for overseeing the implementation and management of compliant systems within the company. The ideal candidate will have a proven track record in implementing and managing advanced IT systems within a pharmaceutical environment. The role will focus on new technological advancements (including Artificial Intelligence and Large Language Models), managing existing systems, maintaining the compliance, supporting various regulatory and customer audits etc. this role requires a deep understanding of pharmaceutical regulatory requirements and the ability to lead/support various projects, including electronic Quality Management System (EQMS) implementation, Laboratory Investigation Management System (LIMS) and Electronic Batch Manufacturing Record (EBMR) implementation etc. The IT Lead will also handle generic IT roles and responsibilities, with a focus on the specific needs of the pharmaceutical sector.

Responsibilities:

• Implementing Compliant Systems: Ensure all IT systems comply with industry regulations and standards, including data integrity controls as specified from GxP, GAMP, FDA, MHRA, and other relevant guidelines.

• Managing Existing Systems: Oversee the maintenance and optimisation of current IT infrastructure, ensuring seamless operation and compliance.

• Project Support: Lead and support projects such as electronic QMS implementation, electronic batch manufacturing record implementation, laboratory investigation management system and other IT initiatives aimed at improving operational efficiency and compliance.

• IT Governance: Develop and enforce IT policies and procedures to ensure data integrity, security, and compliance.

• Vendor Management: Collaborate with external vendors to procure and manage IT solutions that meet the specific needs of the pharmaceutical industry.

• Training and Development: Provide training and support to staff on new systems and technologies, ensuring they are equipped to meet regulatory requirements.

• Technical Support: Offer technical support and troubleshooting for IT-related issues, ensuring minimal disruption to operations.

• Software Qualification: Lead and support on technical & software system qualification and ongoing compliance activities.

• Innovation and Improvement: Stay updated with the latest industry trends and technologies, recommending and implementing improvements to enhance IT capabilities.

• Cybersecurity Management: Develop and implement cybersecurity strategies to protect sensitive data and IT infrastructure from cyber threats. Ensure compliance with cybersecurity regulations and standards.

• Risk Assessment: Conduct regular risk assessments to identify vulnerabilities and implement measures to mitigate potential threats.

• Incident Response: Establish and maintain an incident response plan to address and manage cybersecurity incidents effectively.

• Audit Management: Timely support on managing the regulatory inspections, client audits to ensure the IT systems and compliance are sufficiently represented.

• Automation: Explore, propose, implement and project manage/support various automation projects as per the management intention.

Person Specification:

• Experience of working in a GxP environment within Pharmaceutical or similar industry.

• Excellent interpersonal skills, organised, efficient and motivated self-starter

• Problem solver with excellent attention to detail

• Bachelor’s degree in information technology, Computer Science, or a related field; advanced degree preferred.

• Extensive experience in the pharmaceutical industry, with a focus on IT systems implementation, management and GXP compliance

• Expertise in cybersecurity management and risk assessment.

• Strong knowledge of Electronic Pharmaceutical Quality Systems (EPQS), Laboratory Investigation Management Systems (LIMS), and Electronic Batch Manufacturing Records (EBMR).

• Excellent problem-solving skills and the ability to work under pressure.

• Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.

• Proven leadership experience, with a track record of managing and developing high-performing IT teams.

• Must have the right to work in the UK

What we can offer

• Competitive salary

• Private healthcare

• Pension contributions

• Life assurance

Location
Swavesey, Cambridge

To apply for this role, please send your CV and covering letter to recruitment@4basebio.com

We are expanding our MSAT team at our site just north of Cambridge, UK to facilitate the purification of synthetic DNA products for use in AAV, IVT mRNA processes and other therapeutic areas. We are looking for dynamic and experienced team members to help us achieve our ambitions and goals. 

The role will support the development, optimisation and validation of new products within the company.

In addition, there will be opportunity for the candidate to interact with multi-disciplinary teams within the Research department and expand their laboratory skill set.

Responsibilities:

• Work to develop and optimise new and existing DNA products

• Perform screening and optimisation experiments using 4basebio DNA

• Generate documentation, such as reports/experimental write-ups, that support the development & optimisation of production processes

• Support troubleshooting activities and assist with continuous improvement initiatives

• Work to develop and optimise processes within MSAT, to ensure successful manufacture of DNA products

• Perform analysis of experimental data

• Work collaboratively to support the R&D and manufacturing functions of the Company

• Record experimental methods and results to a high standard and in-line with company guidelines

• Present commercial data to a high standard in internal meetings

• Keep up to date with relevant scientific and technical developments 

• 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

• Undertake any other appropriate roles and responsibilities that reasonably fall within the role holder’s skills and experience as requested

• Be prepared to travel to other 4basebio sites

Person Specification:

• BSc in biological sciences, or a related discipline

• Experience of experimental planning, experimental design and data analysis is required

• Extensive practical experience of techniques including gel electrophoresis, DNA & RNA handling and DNA quantification is required

• Strong knowledge and practical experience in molecular biology techniques

• Highly confident in pipetting techniques

• Excellent team working and communication skills

• Excellent record keeping skills

We are expanding our R&D teams at our site in Cambridge, UK to facilitate the scaling of our proprietary DNA manufacturing process including RNA synthesis and development of nanoparticle vectors for nucleic acid delivery. We are looking for dynamic and experienced team members to help us achieve our ambitions and goals.

Job purpose:

To contribute to new client or collaborator on RNA synthesis and related R&D projects. Contribute to development of novel RNA based products offering solutions in therapeutic and applied space.

Responsibilities:

• Work as part of the RNA team, to be able of generating consistent and valuable data for collaborative and client based projects

• Perform screening and optimisation experiments using 4basebio DNA for in vitro transcription (IVT) for various applications (mRNA, saRNA and circRNA)

• Perform RNA purification and analytics on mRNA and saRNA produced with IVT

• Nanopore based direct RNA sequencing of IVT products and its analysis

• Execute and deliver projects to a high standard and in accordance with project plans

• Analyse and interpret experimental data; identify and solve experimental problems

• Work collaboratively and support the R&D functions of the company

• Record experimental methods and results to a high standard and in-line with company guidelines

• Attend and participate in relevant meetings, training, and development sessions

• Keep up to date with relevant scientific and technical developments

• Undertake any other appropriate roles and responsibilities that reasonably fall within the role holder’s skills and experience as requested

• Use and maintain company equipment in accordance with the company’s SOPs and health & safety guidelines

Person Specification:

• MSc with relevant experience or PhD in biological sciences, molecular biology, or in life sciences

• Hands-on experience working in molecular biology preferably RNA related projects in R&D labs

• Knowledge and practical experience in molecular biology with focus on RNA based techniques

• Experience in analytical techniques including agarose and polyacrylamide gel electrophoresis, nanopore RNA sequencing, capillary electrophoresis, ELISA, qPCR, flow cytometry, dot blot

• Excellent record keeping skills

• Ability to test and troubleshoot new assays and techniques

• Excellent team working and communication skills

This role description may be subject to amendment to take account of changing circumstances but such amendments will only be made following consultation between the post-holder and line manager/head of department.