Laboratory Specialist (f/m/x) - Analytical Testing

Laboratory Specialist (f/m/x) Analytical Support

The Laboratory Specialist contributes to the execution of analytical activities that enable the characterization, monitoring, and lifecycle management of therapeutic products and associated processes.
The role performs routine and moderately complex analytical tasks, supports method execution, and ensures reliable data generation in alignment with established procedures, quality standards, and regulatory expectations.

The incumbent applies foundational scientific knowledge and practical laboratory skills to conduct laboratory analyses, operate instruments, and document results. Working under moderate supervision, the role supports analytical method execution across early development, late-stage readiness, and commercial lifecycle activities. Operating within a matrix environment, the Laboratory Specialist collaborates with the IPT and cross-functional partners to ensure analytical readiness, consistent data quality, and effective laboratory operations that support technical decision-making.

Main Responsibilities & Accountabilities

• Perform routine and moderately complex analytical testing according to SOPs, established test methods, and regulatory expectations.
• Support sample preparation, instrument setup, system suitability checks, and execution of analytical workflows (e.g., chromatography, electrophoresis, spectroscopy).
• Document all analytical activities accurately, contemporaneously, and in compliance with Good Documentation Practices (GDP).
• Ensure timely, accurate, and contemporaneous documentation of all activities in Electronic Laboratory Notebook (ELN) systems and other electronic data-capture tools, maintaining full compliance with data-integrity standards.
• Conduct basic troubleshooting of analytical methods and laboratory equipment under the direction of senior team members.
• Perform preliminary data review, identify irregularities, and communicate observations promptly to supervisors or project leads.
• Support method lifecycle activities including method qualification, optimization, and transfer tasks.
• Maintain laboratory readiness, including equipment qualification support, ordering and managing consumables, and ensuring compliant laboratory conditions.
• Provide factual inputs for deviations, investigations, CAPAs, and change control processes related to analytical work.
• Collaborate with IPT and cross-functional stakeholders (e.g., Process Development, MS&T, QC) to ensure robust analytical execution aligned with program objectives.
• Uphold EHS standards and contribute to maintaining a safe, compliant, and well-organized laboratory environment.
• Identify opportunities to improve analytical workflows, documentation practices, and operational efficiency.

• Bachelor's degree in Analytical Chemistry, Biochemistry, Life Sciences, or a related scientific discipline, or equivalent practical laboratory experience.
• 5 years of laboratory experience in an analytical or process-development environment (industry or academia).Foundational experience with analytical techniques such as HPLC/UPLC, CE, SDS-PAGE, UV/Vis spectroscopy, or comparable platforms.
• Awareness of analytical method execution principles, data-integrity expectations, and regulated laboratory practices.
• Strong attention to detail and demonstrated ability to generate reliable, high-quality analytical data.
• Ability to learn new analytical techniques and laboratory workflows quickly under limited supervision.
• Good communication skills and willingness to collaborate within multidisciplinary teams.
• Demonstrated interest in continuous improvement and laboratory excellence.