Career Opportunity Senior Scientist - Cell Line Development and Gene Therapy About the job FTC South Dublin Our biopharmaceutical research client in Dublin is looking for a Senior Scientist to support and drive Biologics (mAB and recombinant proteins) and Gene Therapy research and development. These dynamic and exciting areas of research have rapidly expanded in recent years, offering novel and real-world treatment options for patients suffering from recalcitrant and life-limiting conditions. Key Responsibilities Attending scheduled training and developing expertise in relevant instrumentation and techniques. Developing and validating methods and Standard Operating Procedures. Performing experiments with high precision, reproducibility, quality control and validation. Generating and completing records, with precision and accuracy in a timely manner. Troubleshooting experimental issues and bottlenecks to facilitate continued process and operational improvement. Designing and optimising vectors for biologics and ATMP applications. Developing and validating methods for improved Biologics and Gene Therapy generation, performance, efficacy and applicability across a broader spectrum of applications. Providing leadership and mentorship in experimental design and development of robust project structures and plans. Providing leadership for establishment of efficiencies and operational excellence in laboratory operations. Supporting and developing project opportunities with academic and industry groups for advancement of biologics research and ATMP research. Generating and presenting publication-ready protocols, data and reports to stakeholders collaborators and clients. Representing the client at conferences and forums and engaging relevant stakeholders regarding ongoing research and development opportunities. Providing considered advice regarding engagement with pan-European consortia and other large groups in the Biologics and Gene Therapy space. Qualifications & Experience PhD in biotechnology, cell biology, molecular biology or another relevant field. Research experience or industrial experience in biotechnology or biopharmaceuticals is required. A strong record in Biologics and Gene Therapy development and characterisation. Significant experience in cloning and vector design work. Excellent cell culture skills, including CHO and HEK cell culture. Demonstrated expertise developing mammalian expression technologies for the generation of monoclonal antibodies, recombinant proteins and / or multi-specific proteins. Experience in Biologics development using a wide range of expression platforms. Experience of mammalian cell line optimisation, clone isolation, characterisation, and banking. Experience in antibody characterisation techniques for assessment of kinetics, affinity and competitive binding using SPR or other techniques. Experience in RT-PCR, dPCR, Sanger or other types of sequence characterisation. #J-18808-Ljbffr
Fastnet Executive Search as excited to partner with our long-standing pharmaceutical client to appoint a Head of Quality in 2026. The successful candidate will be accountable for leading and developing the Quality function at their Cork based manufacturing facility, ensuring full compliance with cGMP, regulatory requirements, and corporate standards. This pivotal role spans Quality Assurance, Quality Control, EHS, and Validation , and will be instrumental in supporting an ongoing major site expansion project, ensuring that quality is embedded across all phases of growth. As a member of both the Site Leadership Team and the Global Quality Team , the Head of Quality will contribute to shaping site and corporate strategy, drive a culture of continuous improvement, and provide leadership to cross-functional teams. Key Responsibilities Strategic & Leadership Lead, coach, and develop high-performing QA, QC, EHS, and Validation teams. Act as a key member of the Site Leadership Team, contributing to site-wide decision-making, operational planning, and strategic development. Serve as the quality interface between the site and the Global Quality, ensuring alignment on policies, standards, and objectives. Build and sustain a strong quality culture focused on accountability, collaboration, and compliance. Represent Quality in all major project planning and execution activities, including a significant site expansion and new product introductions. Quality Assurance Oversee all QA operations, including batch release, deviation and CAPA management, quality systems, documentation, and audits. Ensure effective GMP compliance aligned with regulatory standards (e.g. HPRA). Lead internal and external audits and regulatory inspections, acting as site quality representative. Quality Control Ensure laboratory operations are compliant, efficient, and capable of supporting both routine manufacturing and project needs. Drive analytical method validation and transfer in collaboration with R&D and technical teams. Ensure laboratory data integrity, timely release testing, and continuous improvements in QC processes. Validation Provide strategic oversight of site validation activities, including equipment, processes, cleaning, and computer systems validation. Ensure validation strategies align with lifecycle principles and support new manufacturing capabilities arising from the expansion project. Champion a safety-first culture across the site. Ensure compliance with local and global EHS regulations and company standards. Lead initiatives to minimize environmental impact and promote sustainability. Project Support & Expansion Act as Quality lead for the site’s expansion project, ensuring that new facilities, equipment, and systems meet all applicable regulatory and corporate quality standards. Support capital project planning, risk assessments, commissioning, and qualification activities. Support readiness activities for new production lines and technology transfers. Qualifications & Experience Degree in Science or related life science field. Minimum of 5 years’ experience in pharmaceutical manufacturing, in a senior Quality leadership role. Strong working knowledge of API manufacturing processes, cGMP, ICH guidelines, and regulatory requirements. Proven experience leading multi-disciplinary teams (QA, QC, Validation, EHS). Experience supporting large-scale capital projects and/or site expansions. Prior exposure to inspections by major health authorities (e.g. HPRA). Advanced training in leadership, lean manufacturing, or quality systems. Core Competencies & Attributes Leadership: People-focused leader with a track record of building high-performing teams. Strategic Thinking: Ability to align quality initiatives with long-term business and operational goals. Communication: Excellent communicator across all levels, with the ability to influence and drive cross-functional collaboration. Decision-Making: Strong analytical skills with sound judgment and risk-based decision-making. Change Management: Comfortable leading through complexity and change, particularly in a growing and evolving environment. This is a unique opportunity to shape the future of a growing API manufacturing site, contribute to a transformative expansion project, and play a critical role in elevating quality standards within a global organisation. The Head of Quality will not only safeguard compliance but will be empowered to drive innovation, operational excellence, and cultural transformation. #J-18808-Ljbffr
A prominent pharmaceutical firm in Cork seeks a Head of Quality to lead the Quality function in a major site expansion. The successful candidate will ensure compliance with cGMP and regulatory standards while overseeing multi-disciplinary teams. This pivotal role includes responsibility for Quality Assurance, Control, EHS, and Validation. Candidates should have a degree in a relevant scientific discipline and extensive experience in pharmaceutical manufacturing. This position offers a unique opportunity to drive quality standards within a global organization while fostering a culture of continuous improvement. #J-18808-Ljbffr
About the job Role Purpose Our client in Dublin is looking for a Postdoctoral Researcher to join their team. This role offers a unique opportunity to contribute to the development of an innovative dual-cell therapy targeting neonatal hypoxia-associated brain injury. Neonatal hypoxic‑ischaemic encephalopathy (HIE) is the second leading cause of infant mortality globally and a major contributor to long-term neurological conditions such as cerebral palsy, epilepsy, and sensory impairments. In Europe and the United States HIE affects approximately 1 to 3 per 1,000 live births. Key Responsibilities Design, establish, and optimize in vitro hypoxia models relevant to neonatal brain injury. Validate models for reproducibility and translational relevance. Conduct proteomic and transcriptomic (RNA-seq) analyses to elucidate the mechanism of action (MoA) of MSC and ECFC co‑therapy. Integrate multi‑omics data to identify key therapeutic pathways and biomarkers. Define and characterize critical quality attributes (CQAs) for both MSCs and ECFCs, including identity, purity, viability, and immunophenotype. Develop and implement robust assays to monitor CQAs. Design and validate a potency matrix that reflects the therapeutic function of the dual‑cell product. Correlate potency metrics with MoA and preclinical efficacy data. Develop release assays to ensure product consistency and compliance with regulatory standards. Collaborate with consortium members to integrate assays into GMP and downstream activities. Design and implement cell‑based assays for functional characterisation and screening of therapeutic leads. Analyse complex datasets from omics platforms and functional assays. Prepare detailed reports and presentations for internal and external stakeholders. Present findings at consortium meetings, scientific conferences, and stakeholder briefings. Qualifications & Experience PhD in neuroscience, cell therapy, regenerative medicine, or a related scientific field and a minimum of 3 years of relevant postdoctoral experience. Proven experience in developing and validating in vitro and/or in vivo models of hypoxia or neurovascular injury. Strong expertise in cell biology, particularly with mesenchymal stromal cells (MSCs) and endothelial colony‑forming cells (ECFCs). Demonstrated experience in proteomics and transcriptomics (e.g. RNA‑seq) for mechanism of action studies. Experience in defining and assessing critical quality attributes (CQAs) such as identity, purity, and viability. Track record in developing potency assays and release criteria for advanced therapy medicinal products (ATMPs). Hands‑on experience with neuronal models and their application in neurodegenerative or neurodevelopmental research. Experience in leading or mentoring research staff or students. #J-18808-Ljbffr
