Are you passionate about Quality Control, with expertise in Molecular Biology, Cell Biology, or Stem Cell Biology? Do you have significant industry experience in Quality Control for Advanced Therapies, particularly within Cell and Gene Therapy? If so, this could be a unique opportunity for an ambitious individual to join a rapidly growing organization focused on cutting-edge stem cell innovation. The Role: As a Senior Scientist, you will report to the Associate Director of QC & GMP Analytical Development and will be responsible for implementing QC testing for cell banks, starting materials, drug substance, and drug product to support clinical manufacturing of a cell therapy candidate. This is an exciting opportunity to contribute to the development of next generation cell therapies, collaborating with teams across quality, regulatory, and CMC. Key responsibilities include: Leading method transfer, establishment, and qualification of assays for QC release of a novel engineered cell therapy, including flow cytometry, ddPCR and/or qPCR, and cell based functional assays. Participating in the selection of contract testing organizations (CTOs) and contract development and manufacturing organizations (CDMOs) for analytical methods required for testing starting materials, drug substance, and drug product. Collaborating with the analytical development team to ensure method readiness for transfer to GMP testing labs. Working with quality assurance and regulatory teams to incorporate current regulations and guidance into the testing approach. Skills and Experience Required: Strong experience in Quality Control, ideally within a Biologics, Cell Therapy/ATMP, or Biopharmaceutical organization. Solid understanding of qPCR or ddPCR. Educational background in Molecular Biology, Cell Biology, Biological Science, Stem Cell Biology, or a related field. Excellent communication skills and the ability to work with individuals at all levels. Proactive, driven, pragmatic, open minded, emotionally intelligent, and respectful approach to work. Benefits: Competitive salary. Opportunity to work on cutting edge therapies and technologies in a growing field. Dynamic, cross functional work environment that encourages collaboration. This is a permanent position offering the chance to contribute to the development of next generation cell therapies in a fast paced, innovative environment.
Jan 10, 2026
Full time
Are you passionate about Quality Control, with expertise in Molecular Biology, Cell Biology, or Stem Cell Biology? Do you have significant industry experience in Quality Control for Advanced Therapies, particularly within Cell and Gene Therapy? If so, this could be a unique opportunity for an ambitious individual to join a rapidly growing organization focused on cutting-edge stem cell innovation. The Role: As a Senior Scientist, you will report to the Associate Director of QC & GMP Analytical Development and will be responsible for implementing QC testing for cell banks, starting materials, drug substance, and drug product to support clinical manufacturing of a cell therapy candidate. This is an exciting opportunity to contribute to the development of next generation cell therapies, collaborating with teams across quality, regulatory, and CMC. Key responsibilities include: Leading method transfer, establishment, and qualification of assays for QC release of a novel engineered cell therapy, including flow cytometry, ddPCR and/or qPCR, and cell based functional assays. Participating in the selection of contract testing organizations (CTOs) and contract development and manufacturing organizations (CDMOs) for analytical methods required for testing starting materials, drug substance, and drug product. Collaborating with the analytical development team to ensure method readiness for transfer to GMP testing labs. Working with quality assurance and regulatory teams to incorporate current regulations and guidance into the testing approach. Skills and Experience Required: Strong experience in Quality Control, ideally within a Biologics, Cell Therapy/ATMP, or Biopharmaceutical organization. Solid understanding of qPCR or ddPCR. Educational background in Molecular Biology, Cell Biology, Biological Science, Stem Cell Biology, or a related field. Excellent communication skills and the ability to work with individuals at all levels. Proactive, driven, pragmatic, open minded, emotionally intelligent, and respectful approach to work. Benefits: Competitive salary. Opportunity to work on cutting edge therapies and technologies in a growing field. Dynamic, cross functional work environment that encourages collaboration. This is a permanent position offering the chance to contribute to the development of next generation cell therapies in a fast paced, innovative environment.
Job Description Summary The (Senior) Laboratory Manager reports to the Director, Laboratory Operations and oversees testing of clinical samples at Alderley Park. In addition, this role provides strategic leadership and direct management of laboratory teams, ensuring staff are supported, coached, and developed to achieve both individual and organizational goals. The (Senior) Laboratory Manager is accountable for day-to-day laboratory operations, resource allocation, safety compliance, and fostering a culture of collaboration, innovation, and continuous improvement. About the Role Provide on-site leadership for a high-throughput clinical genome sequencing laboratory, including technical troubleshooting, developing and writing operational procedures, setting laboratory key performance indicators, and establishing quality metrics. Deliver regulatory, due diligence, and internal auditing support. Must have experience working in an ISO 15189 or CAP diagnostic laboratory and be able to apply the associated requirements to clinical diagnostic operations. This role requires a proactive leader who can balance scientific rigor with operational excellence, guiding teams through complex projects while ensuring compliance, efficiency, and staff development. Duties and Responsibilities Team Leadership & Management Supervise, mentor, and develop laboratory staff, including scientists, technicians, and support personnel. Conduct performance reviews, set clear objectives, and foster accountability. Promote a positive and inclusive team culture that encourages collaboration, innovation, and professional growth. Laboratory Operations Design and implement processes and procedures to ensure efficient turnaround times and accuracy of results. Oversee daily laboratory operations, including workflow optimization, resource allocation, and equipment maintenance. Ensure strict adherence to established quality control guidelines and safety protocols. Strategic & Financial Management Prepare and manage laboratory budgets, monitor expenditures, and optimize resource utilization. Establish and track laboratory KPIs and quality metrics to drive continuous improvement. Compliance & Accreditation Ensure all processes comply with national regulations, organizational policies, and accreditation requirements. Maintain ISO 15189, CAP, and other accreditation standards, including preparation for audits and inspections. Continuous Improvement & Innovation Lead initiatives for process improvement, automation, and adoption of new technologies. Encourage staff participation in problem-solving and innovation to enhance laboratory efficiency and service delivery. Stakeholder Engagement Collaborate with customers and cross-functional teams to align laboratory operations with clinical and research objectives. Communicate effectively with internal and external stakeholders, providing updates on laboratory performance and compliance. Experience Minimum of a Master's degree in a relevant subject; PhD desirable. Extensive clinical experience with various techniques; high-throughput DNA sequencing in a commercial, academic, or government laboratory desirable. Experience with clinical assay development, process development, and project management. Proven track record in team leadership, staff development, and laboratory management. Strong background in Quality Assurance and Quality Control applications in clinical diagnostics. Detail-oriented, highly organized, with excellent verbal and written communication skills. Ability to troubleshoot technical applications and manage laboratory automation systems. Knowledge, Skills, and Abilities Leadership Skills: Ability to inspire, motivate, and develop staff while managing performance and fostering collaboration. Language: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Math Ability: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Computer Skills: Proficiency in Microsoft Word, Outlook, and Excel, with the ability to operate laboratory computer systems. Special Skills: Effective interpersonal communication across departments and teams. Strong knowledge of quality control practices and regulations of UKAS, ISO 15189, CAP, and other regulatory agencies.
Jan 09, 2026
Full time
Job Description Summary The (Senior) Laboratory Manager reports to the Director, Laboratory Operations and oversees testing of clinical samples at Alderley Park. In addition, this role provides strategic leadership and direct management of laboratory teams, ensuring staff are supported, coached, and developed to achieve both individual and organizational goals. The (Senior) Laboratory Manager is accountable for day-to-day laboratory operations, resource allocation, safety compliance, and fostering a culture of collaboration, innovation, and continuous improvement. About the Role Provide on-site leadership for a high-throughput clinical genome sequencing laboratory, including technical troubleshooting, developing and writing operational procedures, setting laboratory key performance indicators, and establishing quality metrics. Deliver regulatory, due diligence, and internal auditing support. Must have experience working in an ISO 15189 or CAP diagnostic laboratory and be able to apply the associated requirements to clinical diagnostic operations. This role requires a proactive leader who can balance scientific rigor with operational excellence, guiding teams through complex projects while ensuring compliance, efficiency, and staff development. Duties and Responsibilities Team Leadership & Management Supervise, mentor, and develop laboratory staff, including scientists, technicians, and support personnel. Conduct performance reviews, set clear objectives, and foster accountability. Promote a positive and inclusive team culture that encourages collaboration, innovation, and professional growth. Laboratory Operations Design and implement processes and procedures to ensure efficient turnaround times and accuracy of results. Oversee daily laboratory operations, including workflow optimization, resource allocation, and equipment maintenance. Ensure strict adherence to established quality control guidelines and safety protocols. Strategic & Financial Management Prepare and manage laboratory budgets, monitor expenditures, and optimize resource utilization. Establish and track laboratory KPIs and quality metrics to drive continuous improvement. Compliance & Accreditation Ensure all processes comply with national regulations, organizational policies, and accreditation requirements. Maintain ISO 15189, CAP, and other accreditation standards, including preparation for audits and inspections. Continuous Improvement & Innovation Lead initiatives for process improvement, automation, and adoption of new technologies. Encourage staff participation in problem-solving and innovation to enhance laboratory efficiency and service delivery. Stakeholder Engagement Collaborate with customers and cross-functional teams to align laboratory operations with clinical and research objectives. Communicate effectively with internal and external stakeholders, providing updates on laboratory performance and compliance. Experience Minimum of a Master's degree in a relevant subject; PhD desirable. Extensive clinical experience with various techniques; high-throughput DNA sequencing in a commercial, academic, or government laboratory desirable. Experience with clinical assay development, process development, and project management. Proven track record in team leadership, staff development, and laboratory management. Strong background in Quality Assurance and Quality Control applications in clinical diagnostics. Detail-oriented, highly organized, with excellent verbal and written communication skills. Ability to troubleshoot technical applications and manage laboratory automation systems. Knowledge, Skills, and Abilities Leadership Skills: Ability to inspire, motivate, and develop staff while managing performance and fostering collaboration. Language: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Math Ability: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Computer Skills: Proficiency in Microsoft Word, Outlook, and Excel, with the ability to operate laboratory computer systems. Special Skills: Effective interpersonal communication across departments and teams. Strong knowledge of quality control practices and regulations of UKAS, ISO 15189, CAP, and other regulatory agencies.
MSAT Scientist Location: Edinburgh BioQuarter, Little France Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people's lives. Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science. Find out more about what we do here! Why join us? The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career. A generous salary package - we reward our people at the level they deserve. 31 days of annual leave, plus 4 public holidays which increases with tenure. A competitive company pension scheme to help you save for the future. Group Life Cover - you are automatically covered for three times your basic salary to give you and your family peace of mind. Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us. Flexible benefits such as retail discounts and access to the Cycle2Work scheme. Your new role An exciting opportunity for a MSAT Scientist to join our team. You will be responsible for providing technical support to cell and gene therapy manufacturing processes including: Introduction of new process changes Identifying process improvements and their implementation Implementation of required process documentations to support manufacturing. Support with process monitoring and review process performance Identification, technical/quality assessment and introduction of new materials to manufacturing bill of materials. Providing support for on-floor process trouble shooting, escalation and resolution Quality investigations/out of specification investigations. Provisions of on the floor technical mentoring and guidance to Manufacturing personnel within the cleanroom Manufacturing suite. You will work directly with an MSAT Principal Scientist and collaborate with both internal teams and clients to deliver assigned technical projects/tasks ensuring project timelines are met according to internal and/or customer expectations. You will be an integral part of cross functional project teams including Process Development, Manufacturing, QC, QA, Supply Chain and Project Management to support on-going manufacturing. Write process change controls, validation protocols, risk assessments, batch records and other relevant documentation for both ongoing and new manufacturing processes. Develop new technical protocols, reports and any associated technical documentation to support process transfer and ongoing manufacturing projects. Provide specialist training to manufacturing staff supporting the introduction of new manufacturing processes, changes, and improvements. Support (as SME) technical investigations and out of specifications generating, reviewing, and approving technical reports to support timely close-out of QMS. Support critical process troubleshooting, manage any process escalation being on-call and on-site when required during out of hours and weekends for critical stages of manufacturing. About you Experience within GMP manufacturing and/or process technology transfer roles preferably in the Cell and Gene therapy industry. Hands on cGMP experience with cell culture (2D or 3D system) and other manufacturing process activities. Experience working to EU, MHRA and FDA regulations. Experience in writing technical documents such as process change controls, validation protocols, batch records and standard operating procedures. Excellent attention to detail, proven problem solver, self motivated and positive with a desire to develop technically in your area of expertise. Can do attitude with a determination to succeed and provide solution to complex problems. Contributes to identifying and completing continuous improvement activities to reduce costs, increase yield and productivity for the area. Good organisational and planning skills with the ability to plan whilst delivering results to deadline. Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format to both technical and non technical audiences. Proven ability to learn and share knowledge with the rest of the manufacturing team and enable them to successfully perform new manufacturing processes. Qualifications A degree in a Life Science discipline or relevant equivalent experience.
Jan 09, 2026
Full time
MSAT Scientist Location: Edinburgh BioQuarter, Little France Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people's lives. Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science. Find out more about what we do here! Why join us? The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career. A generous salary package - we reward our people at the level they deserve. 31 days of annual leave, plus 4 public holidays which increases with tenure. A competitive company pension scheme to help you save for the future. Group Life Cover - you are automatically covered for three times your basic salary to give you and your family peace of mind. Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us. Flexible benefits such as retail discounts and access to the Cycle2Work scheme. Your new role An exciting opportunity for a MSAT Scientist to join our team. You will be responsible for providing technical support to cell and gene therapy manufacturing processes including: Introduction of new process changes Identifying process improvements and their implementation Implementation of required process documentations to support manufacturing. Support with process monitoring and review process performance Identification, technical/quality assessment and introduction of new materials to manufacturing bill of materials. Providing support for on-floor process trouble shooting, escalation and resolution Quality investigations/out of specification investigations. Provisions of on the floor technical mentoring and guidance to Manufacturing personnel within the cleanroom Manufacturing suite. You will work directly with an MSAT Principal Scientist and collaborate with both internal teams and clients to deliver assigned technical projects/tasks ensuring project timelines are met according to internal and/or customer expectations. You will be an integral part of cross functional project teams including Process Development, Manufacturing, QC, QA, Supply Chain and Project Management to support on-going manufacturing. Write process change controls, validation protocols, risk assessments, batch records and other relevant documentation for both ongoing and new manufacturing processes. Develop new technical protocols, reports and any associated technical documentation to support process transfer and ongoing manufacturing projects. Provide specialist training to manufacturing staff supporting the introduction of new manufacturing processes, changes, and improvements. Support (as SME) technical investigations and out of specifications generating, reviewing, and approving technical reports to support timely close-out of QMS. Support critical process troubleshooting, manage any process escalation being on-call and on-site when required during out of hours and weekends for critical stages of manufacturing. About you Experience within GMP manufacturing and/or process technology transfer roles preferably in the Cell and Gene therapy industry. Hands on cGMP experience with cell culture (2D or 3D system) and other manufacturing process activities. Experience working to EU, MHRA and FDA regulations. Experience in writing technical documents such as process change controls, validation protocols, batch records and standard operating procedures. Excellent attention to detail, proven problem solver, self motivated and positive with a desire to develop technically in your area of expertise. Can do attitude with a determination to succeed and provide solution to complex problems. Contributes to identifying and completing continuous improvement activities to reduce costs, increase yield and productivity for the area. Good organisational and planning skills with the ability to plan whilst delivering results to deadline. Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format to both technical and non technical audiences. Proven ability to learn and share knowledge with the rest of the manufacturing team and enable them to successfully perform new manufacturing processes. Qualifications A degree in a Life Science discipline or relevant equivalent experience.
AtOXB, our people are at the heart of everything we do. We're on a mission to enable life-changing therapies to reach patients around the world-and we're looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful. We are currently recruiting for aScientist III to join the Quality Control team. In this role, you will perform and report laboratory-based experiments or analytical investigationsin accordance withscientific or regulatory requirements, playing a key part in advancing our mission and making a real difference. Your responsibilities in this role would be: Perform analytical testing as part of QC release and stability. Timely and accurate completion of GxP paperwork. Identifying non-conformances (OOS, OOE, CC) and completion under supervision. Personally responsible for the completion of tasks in relation to their criticality. Joint responsibility for maintenance and compliance of a GxP laboratory area and GxP "housekeeping" procedures. Work will be conducted in accordance with the OXB Quality Management system. High regard for safety and display a high level of good laboratory citizenship. We are looking for: Educated to a minimum of BSc Degree in a relevant discipline (biology, biomedicine etc), or basic experience of working in a related environment. Flow cytometry and tissue culture experience desirable. Some demonstrablecompetencies in performing laboratory tasks and general experimental procedures. Understanding of laboratory health and safety requirements. Computer Literacy with MS Word, Excel & Outlook & Teams. Some appreciation of LaboratoryInformation Management Systems (LIMS) Understanding of regulatory requirements e.g. GMP, GLP, GCP and/or Validation and Quality Management systems. Some familiarity with the regulatory requirements for analytical work (e.g. product specifications, stability testing guidelines etc). Highly motivated and enthusiastic. Ability to work well in a team. About Us: OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than30years of experience in viral vectors; the driving force behind the majority ofgene therapies. OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturingexpertisein lentivirus, adeno-associated virus (AAV)and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatoryexpertise. Why Join Us? Wellbeing programmesthat support your mental and physical health Career development opportunitiesto help you grow and thrive Supportive, inclusive, and collaborative culture State-of-the-art labs and manufacturing facilities A company that lives its values:Responsible, Responsive, Resilient, Respect We want you to feel inspired every day. AtOXB,we'refuture-focused and growing fast. We succeed together-through passion, commitment, and teamwork.
Jan 09, 2026
Full time
AtOXB, our people are at the heart of everything we do. We're on a mission to enable life-changing therapies to reach patients around the world-and we're looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful. We are currently recruiting for aScientist III to join the Quality Control team. In this role, you will perform and report laboratory-based experiments or analytical investigationsin accordance withscientific or regulatory requirements, playing a key part in advancing our mission and making a real difference. Your responsibilities in this role would be: Perform analytical testing as part of QC release and stability. Timely and accurate completion of GxP paperwork. Identifying non-conformances (OOS, OOE, CC) and completion under supervision. Personally responsible for the completion of tasks in relation to their criticality. Joint responsibility for maintenance and compliance of a GxP laboratory area and GxP "housekeeping" procedures. Work will be conducted in accordance with the OXB Quality Management system. High regard for safety and display a high level of good laboratory citizenship. We are looking for: Educated to a minimum of BSc Degree in a relevant discipline (biology, biomedicine etc), or basic experience of working in a related environment. Flow cytometry and tissue culture experience desirable. Some demonstrablecompetencies in performing laboratory tasks and general experimental procedures. Understanding of laboratory health and safety requirements. Computer Literacy with MS Word, Excel & Outlook & Teams. Some appreciation of LaboratoryInformation Management Systems (LIMS) Understanding of regulatory requirements e.g. GMP, GLP, GCP and/or Validation and Quality Management systems. Some familiarity with the regulatory requirements for analytical work (e.g. product specifications, stability testing guidelines etc). Highly motivated and enthusiastic. Ability to work well in a team. About Us: OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than30years of experience in viral vectors; the driving force behind the majority ofgene therapies. OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturingexpertisein lentivirus, adeno-associated virus (AAV)and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatoryexpertise. Why Join Us? Wellbeing programmesthat support your mental and physical health Career development opportunitiesto help you grow and thrive Supportive, inclusive, and collaborative culture State-of-the-art labs and manufacturing facilities A company that lives its values:Responsible, Responsive, Resilient, Respect We want you to feel inspired every day. AtOXB,we'refuture-focused and growing fast. We succeed together-through passion, commitment, and teamwork.
Job Title: Scientist 2 - Stability Contract: 9 months Location: Deeside Pay: 134 p/d SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. We are seeking a Scientist to join their Deeside team. Duties and Responsibilities : To be responsible for maintaining compliance within the Stability Suites, Stability Laboratory and associated areas to support the determination of product shelf-life and product labelling. The focus of this role will be on Non-Conformance (NC), Corrective Action/Preventative Action (CAPA), and Out of Specification (OOS) investigations. Maintain compliance to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures. Support maintenance, calibration, documentation and updating quality records for Stability equipment. Support any on-site maintenance, service and calibration activities performed by external vendors. Act as Subject Manner Expert (SME) and write Quality documentation such as Change Control Requests (CCRs), Non-Conformances (NCs), Corrective Action/Preventative Action (CAPAs) and Laboratory Out of Specifications (OOS'), ensuring accurate and thorough investigations are complete within required timeframes, incorporating problem-solving and troubleshooting for future improvements. Monitor compliance KPIs within the Stability department and proactively update the management team with trends and improvement initiatives. Ensure the Stability department is audit ready at all times. Supports and provides information for internal and external audits where required in a timely manner. Conduct training sessions on compliance for the Stability department. Support global testing laboratories with compliance requirements as needed. Actively execute improvement ideas (Lean/6S) for the Stability laboratories and suites. Actively supporting with the implementation of the LIMs system. Support bringing in new equipment when required, through planning and execution of Installation, Operational and Performance Qualification activities, liaising with vendors as per company procedures. Ensure the Stability lab, Stability Suites and storerooms are maintained as a safe and compliant working environment, raising near misses where needed. Supporting any other tasks required by the Laboratory Manager/Team Leaders. Skills & Experience: Pref erably 2-3 years' experience working in Medical Device/Pharmaceutical Industry within an R &D/product development or quality department role. Experience in quality and compliance Ability to react and respond positively to changes in priority and workload. Competent in following and adhering to pre-determined stability study protocols, SOPs, OCIs and TDs. Basic experience in the utilisation of computerised systems to manage data and information. Good working knowledge of Microsoft Office - specifically Word and Excel. Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines. Proactive and positive mindset with an attitude that is open to change to embrace new ways of working and improvements. Proven experience leading thorough Quality investigations and implementing effective preventative and corrective measures. Strong communication skills to effectively collaborate cross-functionally. Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
Sep 22, 2025
Seasonal
Job Title: Scientist 2 - Stability Contract: 9 months Location: Deeside Pay: 134 p/d SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. We are seeking a Scientist to join their Deeside team. Duties and Responsibilities : To be responsible for maintaining compliance within the Stability Suites, Stability Laboratory and associated areas to support the determination of product shelf-life and product labelling. The focus of this role will be on Non-Conformance (NC), Corrective Action/Preventative Action (CAPA), and Out of Specification (OOS) investigations. Maintain compliance to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures. Support maintenance, calibration, documentation and updating quality records for Stability equipment. Support any on-site maintenance, service and calibration activities performed by external vendors. Act as Subject Manner Expert (SME) and write Quality documentation such as Change Control Requests (CCRs), Non-Conformances (NCs), Corrective Action/Preventative Action (CAPAs) and Laboratory Out of Specifications (OOS'), ensuring accurate and thorough investigations are complete within required timeframes, incorporating problem-solving and troubleshooting for future improvements. Monitor compliance KPIs within the Stability department and proactively update the management team with trends and improvement initiatives. Ensure the Stability department is audit ready at all times. Supports and provides information for internal and external audits where required in a timely manner. Conduct training sessions on compliance for the Stability department. Support global testing laboratories with compliance requirements as needed. Actively execute improvement ideas (Lean/6S) for the Stability laboratories and suites. Actively supporting with the implementation of the LIMs system. Support bringing in new equipment when required, through planning and execution of Installation, Operational and Performance Qualification activities, liaising with vendors as per company procedures. Ensure the Stability lab, Stability Suites and storerooms are maintained as a safe and compliant working environment, raising near misses where needed. Supporting any other tasks required by the Laboratory Manager/Team Leaders. Skills & Experience: Pref erably 2-3 years' experience working in Medical Device/Pharmaceutical Industry within an R &D/product development or quality department role. Experience in quality and compliance Ability to react and respond positively to changes in priority and workload. Competent in following and adhering to pre-determined stability study protocols, SOPs, OCIs and TDs. Basic experience in the utilisation of computerised systems to manage data and information. Good working knowledge of Microsoft Office - specifically Word and Excel. Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines. Proactive and positive mindset with an attitude that is open to change to embrace new ways of working and improvements. Proven experience leading thorough Quality investigations and implementing effective preventative and corrective measures. Strong communication skills to effectively collaborate cross-functionally. Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
