City Therapeutics

Sr. Scientist, Bioanalytical Biomarker Sciences

Cambridge MA · Senior

Sponsorship not specified$136k-$154kDetected 23 hours ago

FDA RegulatoryBioinformaticsResearchProtein AnalysisCommunicationProblem SolvingAdaptability

About the role

Ensure compliance with applicable regulatory guidelines, SOPs, study protocols, and data integrity principles across all bioanalytical and biomarker-related activities.
Monitor emerging trends and best practices in bioanalytical science, biomarker assay technologies, and analytical platforms, and contribute to the implementation of innovative tools and approaches.
We are seeking a highly motivated and skilled Senior Scientist with expertise in bioanalytical and biomarker assays to join our growing Translational Sciences team.

Responsibilities

Design and execute bioanalytical and biomarker assay development, qualification, and validation activities, including, ligand-binding (ELISA, hybridization ELISA etc.), and immunogenicity assays, both internally and through CRO partners, to support drug candidate selection and regulatory submissions.
Generate and oversee bioanalytical data in partnership with PK scientists to support nonclinical programs and inform dose selection for Phase 1-3 clinical siRNA candidates.
Serve as the bioanalytical and biomarker lead on multidisciplinary project teams, collaborating with chemistry, platform biology, computational biology, clinical, regulatory, CMC, and other cross-functional partners to advance discovery and early development programs.
Manage CRO activities related to bioanalytical and biomarker assay development, qualification, validation, and sample analysis in support of discovery, nonclinical, and CTA/IND-enabling studies.
Prepare high-quality bioanalytical summaries, technical reports, and regulatory document contributions, including sections for INDs/CTAs, Investigator's Brochures, briefing books, and other submission materials.
Lead the preparation, review, and implementation of CRO Statements of Work (SOWs) for bioanalytical and biomarker activities, ensuring clear study scope, deliverables, timelines, assay requirements, sample analysis plans, reporting expectations, and executional alignment with program objectives.
This individual will work closely with internal research teams, cross-functional program partners, and external CROs to support both discovery- and development-stage programs.

Requirements

Ph D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3-5+ years of relevant industry experience, or M.S. with 6+ years of relevant industry experience.
Proficiency across multiple bioanalytical assay platforms, including ligand-binding assays, and immunogenicity assays in support of PK, PD, biomarker, and anti-drug antibody assessments.
Experience managing CRO relationships and externalized bioanalytical activities, including SOW preparation, review, implementation, study execution, data review, and timely delivery of high-quality reports.
Familiarity with regulatory expectations and guidance relevant to early-stage drug development.
Please note this role is required to be on-site at our offices in Cambridge, MA 5 days a week.
Strong expertise in regulated bioanalytical assay development, including assay qualification, validation, and regulatory requirements to support nonclinical and clinical studies.
Demonstrated adaptability, ownership, and collaborative mindset, with the ability to manage diverse responsibilities and shifting priorities in a dynamic, fast-paced environment.
Excellent problem-solving, analytical, and communication skills, with the ability to interpret complex quantitative data and clearly convey key findings to diverse scientific, clinical, regulatory, and cross-functional audiences.

Nice to have

Experience supporting IND/CTA-enabling studies and/or early clinical development programs, including generation and interpretation of bioanalytical data for regulatory submissions.
Knowledge of regulatory bioanalytical guidance and expectations, including FDA, EMA, and ICH guidelines, is a plus.
City Therapeutics is accepting resumes/CVs from direct applicants only.
Recruitment agency submissions will not be accepted at this time.
City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce.
All qualified applicants will receive consideration for employment without regard to race
marital, domestic partnership, or civil union status
sex, gender, gender identity or expression

Compensation

The base salary range provided reflects our current estimate of what we anticipate paying for this position.
Your actual base salary will be based on several factors, including relevant skills, experience, internal equity, relevant education or training and market dynamics.
In addition, this role is eligible for an annual cash bonus and equity compensation.
Per Year Salary Range: $136,000 to $154,000.

Equal opportunity

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race

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