Principal Scientist I
| Posting date: | 23 July 2025 |
|---|---|
| Hours: | Full time |
| Closing date: | 22 August 2025 |
| Location: | Macclesfield, Cheshire |
| Remote working: | On-site only |
| Company: | Synexa Life Sciences |
| Job type: | Permanent |
| Job reference: |
Summary
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.
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.