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Senior Scientist, Bioanalytical Sciences

Senior Scientist, Bioanalytical Sciences

Crescent Biopharma, Inc.Boston, MA, US
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Job Description

Job Description

About Us

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visitwww.crescentbiopharma.comand follow the Company onLinkedInandX.

Position Overview

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.

Education & Experience

  • 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.

    • What We Offer

  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
  • Competitive compensation, including base salary, performance bonus, and equity.
  • 100% employer-paid benefits package.
  • Flexible PTO.
  • Two, one-week company-wide shutdowns each year.
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

    • __

    Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

    We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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    Senior Scientist • Boston, MA, US