Biotechnology Jobs

GSK · London

Provides advanced scientific expertise in safety evaluation and risk management for key oncology assets in clinical development, leading signal detection, benefit-risk assessment and regulatory safety submissions. Represents the Safety Evaluation & Risk Management function on cross-functional clinical matrix and project teams, escalating emerging safety issues to senior governance. Mentors junior staff and partners with Safety Physicians to shape long-term safety strategy.

GSK · Poznan Grunwaldzka · PLN 525,750 – PLN 876,250 pa

Provides advanced scientific expertise in safety evaluation and risk management for key oncology assets in clinical development, leading signal detection, benefit-risk assessment and regulatory safety submissions. Represents SERM on cross-functional clinical matrix teams, escalates emerging safety issues to governance bodies and mentors junior staff within a global matrix environment.

Thermo Fisher Scientific · United Kingdom

Senior physician role leading medical science and strategy for oncology across a clinical research business, shaping RFP responses, bid defences and protocol design while engaging client medical leadership. Also provides therapeutic training, mentoring and regulatory document input, working in a matrixed global team with international travel.

Thermo Fisher Scientific · Stevenage

Primarily lab-based role operating single-use bioreactor systems to culture mammalian cells, mainly CHO lines, for upstream process research. Involves planning and troubleshooting seed train expansion, inoculation, feeding, sampling and harvest, then analysing growth, viability, metabolite and titre data. Works within a client-dedicated multidisciplinary team at a biopharmaceutical site.

AstraZeneca · London

Lead national medical strategy for the Respiratory & Immunology business unit, spanning inhaled therapies and biologics. Define pre-launch and launch medical plans, drive NHS transforming-care initiatives, and oversee MSL and healthcare delivery teams. Provide scientific leadership across regulatory, market access and real-world evidence work.

Autolus · London

Designs end-to-end data solutions spanning data integration, data warehousing, master data management, governance and analytics for a biopharmaceutical company. Translates business requirements into data models, data flows and integration patterns, and leads architecture and design reviews across enterprise applications and cloud data platforms.

Bicycle Therapeutics · Cambridge

Operational backbone of R&D Quality, administering and optimising a validated eQMS (Veeva, TrackWise, Dot Compliance) for GxP document control, training matrices, deviation/CAPA tracking and inspection readiness. Supports FDA, MHRA and EMA inspections and works across clinical, non-clinical and pharmacovigilance teams.

Autolus · Stevenage

Hands-on senior role owning the computerised-system lifecycle for GxP systems, from impact and supplier assessments through validation, release, operation and retirement. Authors and executes CSV documentation, performs data integrity and 21 CFR Part 11 assessments, manages change controls and CAPAs, and supports regulatory inspections as a CSV subject matter expert.

Johnson & Johnson Innovative Medicine · High Wycombe

Independent clinical quality-risk leadership role translating risk signals into proactive mitigation, escalation and inspection readiness across trials and programs. Involves maintaining Clinical Quality Plans, driving risk monitoring reviews, advising on CAPA plans, and leading pre-submission quality portfolio reviews and mock inspections. Combines hands-on risk ownership with cross-functional influence and coaching of team members.

Moderna · Oxford

Hands-on automation engineering role supporting drug product packaging and drug substance manufacturing at a new mRNA facility. Involves commissioning and optimising Emerson DeltaV and Allen-Bradley/Rockwell PLC systems, automated labelling and secondary packaging equipment, plus GxP validation, root cause analysis and lifecycle documentation. Works independently as a technical specialist across manufacturing, engineering, quality and digital teams.

Moderna · Oxford

Perform routine cGMP Quality Control testing using HPLC, UPLC, GC, UV spectroscopy, DLS and Karl Fischer analysis, supporting raw materials, in-process materials, drug substance, product release and stability programs. Coordinate and execute global GMP stability studies, manage sample lifecycles in LabVantage LIMS, trend data statistically, and author protocols and regulatory documentation. The role is 100% onsite at the Harwell facility and involves collaboration with manufacturing, QA, regulatory and external testing partners.

Ipsen · London

Leads global clinical data transparency and disclosure across registries and regulatory platforms such as CTIS, EMA Policy 0070 and Health Canada PRCI, acting as subject matter expert for assigned therapeutic areas. Manages vendor partnerships, FOI access requests, redaction and lay summary work, plus SOP governance, compliance reporting and audit readiness within Global Regulatory Affairs Excellence.

Gilead Sciences · Cambridge

Leads end-to-end Clinical Systems migration initiatives such as CTMS, eTMF and study startup, from strategy and due diligence through implementation, cutover and legacy decommissioning. Oversees data migration programs, CRO integrations and GxP validation, managing vendors, stakeholders and a team of professionals while shaping the Clinical Systems roadmap.

Ipsen · London

Leads one or more Early Development Asset Teams, owning integrated strategy from candidate nomination through first-in-human trials across preclinical, translational, clinical, regulatory and CMC workstreams. Serves as scientific champion for oncology assets, presenting data and investment recommendations to governance bodies and contributing to in-licensing due diligence.

Parexel · London

Provides statistical consulting and strategic advice on optimal study designs and analyses across drug, device, and diagnostic clinical development, including preparation for regulatory authority interactions. Serves as a leader in innovative study designs for client accounts and supports new business through proposals, bids, and client presentations, representing clients at key regulatory meetings.