Principal Scientist I

1 week ago

Macclesfield, Cheshire East, United Kingdom Synexa Life Sciences Full time £60,000 - £100,000 per year

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, 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.

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, 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.

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