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).
* Serve as the SME on complex ligand-binding immunoassays (ELISA, MSD ECL, DELFIA™, AlphaLISA™) 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.
* 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™, 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.
#J-18808-Ljbffr