Synexa Life Sciences (Pty) Ltd.
Macclesfield, Cheshire
Job Purpose The Principal Scientist I (Mass Spectrometry) aids in driving strategic scientific growth within our mass spectrometry 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 bioanalytical assays with predominantly LC MS endpoints. 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 overseeing Value Creation Projects (VCPs) and advancing in house capabilities to expand our assay portfolio. Assay SME & Method Innovation Lead feasibility studies and perform/oversee method development for the complex bioanalytical assays requested by our clients (including small molecules, large molecules, and new modalities at all stages of the development cycle). Lead transfer of the methods to study delivery group for validation and sample analysis, and monitoring study progress as the methods are employed. Serve as the SME for complex bioanalytical assays (scientific rationale, sample preparation, chromatography, mass spectrometry, hybrid applications, trouble shooting etc). Leadership & Mentoring Mentor and train junior and mid level scientists on advanced assay design, troubleshooting, data analysis, regulatory requirements 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 Chemistry, Biochemistry, Biology or related discipline with 2 years' industry experience OR MSc/BSc 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/performing development of bioanalytical LC MS assays for PK and/or PD applications in biological fluids and tissues using triple quadrupole instruments. Excellent leadership, project management, and cross functional collaboration skills. Proven experience in business facing roles: proposal writing, client presentations, and technical negotiations. Strong written and verbal communication skills in English. Preferred Skills & Experience Experience in the bioanalytical quantitation of large molecules and new modalities using LC MS. History of leading or co authoring peer reviewed publications or patents in bioanalysis. Performed role of Study Director/ Principal Investigator/ Responsible Scientist in the support of regulatory studies. Bioanalytical CRO experience. Experienced user of high resolution mass spectrometers. Experience of interactions with health authorities (FDA, EMA, MHRA).
Job Purpose The Principal Scientist I (Mass Spectrometry) aids in driving strategic scientific growth within our mass spectrometry 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 bioanalytical assays with predominantly LC MS endpoints. 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 overseeing Value Creation Projects (VCPs) and advancing in house capabilities to expand our assay portfolio. Assay SME & Method Innovation Lead feasibility studies and perform/oversee method development for the complex bioanalytical assays requested by our clients (including small molecules, large molecules, and new modalities at all stages of the development cycle). Lead transfer of the methods to study delivery group for validation and sample analysis, and monitoring study progress as the methods are employed. Serve as the SME for complex bioanalytical assays (scientific rationale, sample preparation, chromatography, mass spectrometry, hybrid applications, trouble shooting etc). Leadership & Mentoring Mentor and train junior and mid level scientists on advanced assay design, troubleshooting, data analysis, regulatory requirements 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 Chemistry, Biochemistry, Biology or related discipline with 2 years' industry experience OR MSc/BSc 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/performing development of bioanalytical LC MS assays for PK and/or PD applications in biological fluids and tissues using triple quadrupole instruments. Excellent leadership, project management, and cross functional collaboration skills. Proven experience in business facing roles: proposal writing, client presentations, and technical negotiations. Strong written and verbal communication skills in English. Preferred Skills & Experience Experience in the bioanalytical quantitation of large molecules and new modalities using LC MS. History of leading or co authoring peer reviewed publications or patents in bioanalysis. Performed role of Study Director/ Principal Investigator/ Responsible Scientist in the support of regulatory studies. Bioanalytical CRO experience. Experienced user of high resolution mass spectrometers. Experience of interactions with health authorities (FDA, EMA, MHRA).