Senior Scientist, Bioanalytical Sciences
Crescent BiopharmaWant to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Crescent is seeking a Senior Scientist, Bioanalysis to manage bioanalytical activities supporting preclinical and clinical programs. This individual will partner with internal teams and CROs to design, validate/transfer, and oversee bioanalytical assays (e.g., ligand-binding and LC–MS/MS), managing sample analysis, data quality control, interpretation, and reporting to generate high-quality concentration data supporting PK. Responsibilities include planning and authoring bioanalytical documents (plans, protocols, reports), ensuring data integrity and regulatory compliance (GLP/GCP), and managing the operational aspects of outsourced work (budgeting, SOWs, audits, and sample logistics).
Responsibilities
- Assist in the development and execution of bioanalytical (BA) strategies to meet current and future regulatory and scientific requirements.
- Manage the implementation of bioanalytical contracts/SOW, plans, and reports.
- Oversee day-to-day operations of CROs: coordination of shipments of test article, necessary reagents and samples, protocol and data review, provide technical assistance, and report review.
- Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness.
- Coordinate the bioanalysis activities for individual preclinical/clinical programs to ensure alignment of BA data deliverables.
- Contribute to regulatory documents (i.e. IND, CTA, BLA etc.), providing high-quality bioanalytical content and responses to queries.
- Conduct scientific audits of CROs in collaboration with the QA department.
- Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies and safety procedures.
Qualifications
- PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with a minimum of 5 years of industry or related experience.
- Strong understanding of bioanalytical technology and methods both for small and large molecules and peptides.
- Proven experience managing external CROs (SOWs, timelines, budgets, data review) with excellent organizational and project-management skills.
- Well-grounded in drug-development practices—data-driven decision making; contribution to protocols, bioanalytical plans/reports, and clinical study reports.
- Ability to work in a dynamic team-oriented environment as demonstrated by participating in and contributing to cross-functional teams.
- Small molecule DMPK experience is a plus.
Education
- PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with a minimum of 5 years of industry or related experience.