Senior Bioanalytical & Biomarker Scientist

City Therapeutics; Cambridge (MA); On-site; USD 136,000 - 154,000; Full time

Job summary

City Therapeutics in Cambridge, MA, seeks a Sr. Scientist, Bioanalytical Biomarker Sciences, to lead assay development and biomarker work across discovery and early development.

You will oversee CROs, guide PK/PD analyses, and drive data-based decision making from candidate selection through early clinical programs. You will manage cross-functional collaboration, ensure regulatory readiness, and contribute to IND/CTA submissions while strengthening analytical platforms and data integrity.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• MS with 6+ years of relevant industry experience.
• Strong expertise in regulated bioanalytical assay development, qualification, validation.
• Experience managing CRO relationships and externalized bioanalytical activities.
• Familiarity with FDA, EMA, and ICH regulatory expectations.
• Excellent problem-solving, analytical, and communication skills.

Responsibilities

• Design and execute bioanalytical and biomarker assay development, qualification, and validation activities, including ligand-binding and immunogenicity assays.
• Generate and oversee bioanalytical data in partnership with PK scientists to support nonclinical programs and dose selection for clinical candidates.
• Serve as the bioanalytical and biomarker lead on multidisciplinary project teams across discovery and development programs.
• Manage CRO activities related to assay development, qualification, validation, and sample analysis.
• Prepare high-quality bioanalytical summaries, technical reports, and regulatory submission materials.
• Ensure compliance with regulatory guidelines, SOPs, study protocols, and data integrity principles.
• Lead the preparation, review, and implementation of CRO Statements of Work (SOWs).
• Monitor emerging trends and implement innovative tools and approaches.

Skills

Bioanalytical expertise

CRO management

Regulatory understanding

Data interpretation

Communication skills

Cross-functional collaboration

Education

PhD in Analytical Chemistry / Biochemistry / Pharmaceutical Sciences

MS with 6+ years of industry experience

Job description

City Therapeutics in Cambridge, MA, seeks a Sr. Scientist, Bioanalytical Biomarker Sciences, to lead assay development and biomarker work across discovery and early development.

You will oversee CROs, guide PK/PD analyses, and drive data-based decision making from candidate selection through early clinical programs. You will manage cross-functional collaboration, ensure regulatory readiness, and contribute to IND/CTA submissions while strengthening analytical platforms and data integrity.