Biotechnology Jobs

• Zug, Switzerland
• Hybrid · 2 days in office
• US$242,250 – US$403,750 pa
• Director · manages people

Accountable for end-to-end clinical development of a multi-tumor oncology asset, from first-in-human through registrational trials, regulatory approval and launch. Leads cross-functional strategy with research, precision medicine, medical affairs and commercial partners, and represents the program at senior governance forums. Requires deep antibody-drug conjugate and global regulatory experience.

• London
• Hybrid · 2 days in office
• US$242,250 – US$403,750 pa
• Director · manages people

Accountable for end-to-end clinical development strategy for a multi-tumor oncology asset, spanning first-in-human through registrational trials, regulatory filing and initial market launch. Acts as senior clinical representative at governance forums and leads cross-functional, matrixed teams across research, precision medicine, medical affairs and commercial. Requires deep antibody-drug conjugate and global health authority experience.

• London
• Lead · manages people

Provides technical leadership in setting up and operating a CDMO site, leading process development and analytical method development projects for cell therapy manufacture. Plans technology transfers, ensures regulatory compliance, drives continuous improvement, and mentors colleagues while engaging directly with clients.

MHRA · EMA · FDA

• Harrow
• Remote
• Senior

Acts as principal labelling strategist within Global Regulatory Affairs, driving development and maintenance of dCCDS, CCDS, USPI and EU SmPC documents across an assigned product portfolio. Leads Global Labeling Committee reviews of proposed label exceptions and represents labelling on regulatory strategy teams, working with safety, clinical and commercial stakeholders. Home or office based across European locations.

Company Core Data Sheet (CCDS) · Development Company Core Data Sheet (dCCDS) · US Prescribing Information (USPI) +3

• Stevenage
• On-site
• Mid-level

Performs complex sample preparation and quantitative analysis of small molecules and biotherapeutics using instrumentation such as GC-MS, ICP-OES, HPLC and LC-MS, supporting both GMP and non-GMP stability studies. Works largely independently to set up, maintain and troubleshoot analytical instrumentation, interpret data for technical validity and compliance, and report results to client teams. Based full-time onsite at a pharmaceutical client site as part of a functional service provider partnership.

GC-MS · ICP-OES · HPLC +2

• London
• Hybrid · 2–3 days in office
• Junior

Contribute across a full-stack cloud product and IoT devices that interface with hardware automating human cell production. Work spans TypeScript, React, GraphQL frontends and Node.js/PostgreSQL backends, with cross-disciplinary collaboration alongside hardware engineers and biologists, including testing on prototype machines in the lab.

React · TypeScript · GraphQL +7

• Loughborough
• On-site
• Entry level
• Permanent

Performs chemical, physical and microbiological testing of raw materials, in-process, finished and stability samples in a GMP pharmaceutical QC lab. Uses wet chemistry techniques, auto titrators, Karl Fischer, FTIR and UV-Vis, plus LIMS, with instrument calibration, COSHH risk assessments and 6S housekeeping duties.

LIMS · Microsoft Office · Auto Titrators +4

• Cambridge
• Hybrid · 3 days in office
• Director

Provides medical and scientific leadership across late-stage respiratory and immunology clinical programs, from Phase IIb to Phase IV. Involves designing, executing and interpreting pivotal trials, medical monitoring, regulatory document input and building relationships with external scientific experts in an international team.

• Maidenhead
• Hybrid · 3 days in office
• Director · manages people

Leads scientific safety assessments for assigned medicinal products, partnering with Medical Safety Officers to prepare analyses and evaluations for regulatory compliance. Supports Safety Management Teams, conducts proactive safety data reviews, and serves as product point of contact, with hybrid working requiring three days on site.

Microsoft Word · Microsoft Excel · Microsoft PowerPoint

• Maidenhead
• Mid-level · manages people

Leads the preparation and finalisation of clinical documents within the Regulatory Medical Writing team, supporting the Immunology therapeutic area. Takes a lead role on assigned projects for content, scientific strategy, timing and tracking, and manages direct reports including hiring, goal-setting and development. Involves guiding cross-functional teams, peer review and maintaining knowledge of ICH and regulatory guidelines.

• Oxford
• On-site
• Mid-level

Owns product management for ONI's kits and integrated workflows, including the Discovery Kit, EV Profiler and LNP Profiler, ensuring sample prep, fluid handling, imaging, analysis and reporting software operate as one system. Acts as connective tissue between software, hardware, bioware, support and field teams, driving reproducibility, adoption and roadmap across UK and US teams.

Nanoimager · Aplo Platform · Aplo Flow +5

• Cambridge
• Director · manages people

Leads a team of medical writers and oversees strategic planning and drafting of complex regulatory submissions at the therapeutic area or portfolio level. Acts as subject matter expert, driving document strategy with cross-functional teams across Regulatory Affairs, Clinical Research and Clinical Data Science, plus process improvement and training initiatives.

Workday

• Uxbridge
• Hybrid
• Director

Serves as scientific authority for clinical studies across an assigned asset or indication, from protocol development through CSR review and regulatory submission. Leads clinical oversight of study data with Data Management and Programming, may act as Trial Lead on complex global studies, and presents to investigators, KOLs and senior leadership. Also supports process improvement, training and mentoring within the Clinical Capabilities function.