Job Description

Job Purpose

The Principal Scientist I (Immunoassays) aids in driving strategic scientific growth within our Immunoassay group by leading high-impact value-creation initiatives, mentoring junior staff, and expanding in-house capabilities. You will support business development through scientific proposal writing, client interactions, and by serving as a subject-matter expert on advanced ligand-binding and functional immunoassays. Your leadership will champion scientific excellence, reinforce GxP compliance, and elevate our CRO's reputation via publications, workshops, and cross-functional collaborations.

Main Areas of Responsibility

Business Development & Scientific Strategy: Collaborate with BD teams to develop scientific content for proposals, drive technical discussions with clients, and cultivate long-term relationships. Identify emerging industry needs and spearhead Value Creation Projects (VCPs) to expand our assay portfolio (e.g., novel ECL platforms, cell-based effector function assays).

Assay SME & Method Innovation: Serve as the SME on complex ligand-binding immunoassays (ELISA, MSD ECL, DELFIA(TM), AlphaLISA(TM)) and functional assays (ADCC, CDC, reporter gene assays) to aid in development and troubleshooting. Lead feasibility studies and oversee assay development, validation, and technology transfers to routine testing groups.

Leadership & Mentoring: Mentor and train junior and mid-level scientists on advanced assay design, troubleshooting, data analysis, and GxP documentation. Delegate responsibilities and review deliverables to ensure scientific rigor, data integrity, and on-time delivery.

Scientific Excellence & External Engagement: Drive continuous improvement through internal audits, protocol enhancements, and corrective-preventive action initiatives. Represent the company at scientific conferences, workshops, and in peer-reviewed publications to showcase our capabilities and thought leadership.

Qualifications & Experience:

PhD in Immunology, Molecular Biology, Biochemistry, or related discipline with ?2 years' industry experience OR MS in a relevant field with ?7 years' hands-on experience. Deep expertise in regulated bioanalytical environments (GLP/GCP) and familiarity with ICH bioanalytical guidelines. Demonstrated track record leading ligand-binding (ECL, DELFIA(TM), ELISA) and cell-based immunoassays, including method transfer and bridging studies. Proven experience in business-facing roles: proposal writing, client presentations, and technical negotiations. Excellent leadership, project management, and cross-functional collaboration skills. Strong written and verbal communication skills in English. Proficiency with data-analysis software (SoftMax Pro, Prism, Fit-for-Purpose validation tools) and common instrumentation.

Preferred Skills & Experience:

Background in assay automation, high-throughput screening, or multiplex platforms. Familiarity with ERP systems for resource tracking and capacity planning. History of leading or co-authoring peer-reviewed publications or patents in bioanalysis. Quality by Design (QbD) Mindset - familiarity with QbD principles to build robustness into assay development and validation from the outset. Prior involvement in dossier preparation or responses to health-authority queries (e.g., FDA, EMA) for bioanalytical sections of IND/CTA or BLA filings.

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.

Job Type: Full-time

Work Location: In person