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Crescent Biopharma · 1 day ago

Senior Scientist, Bioanalytical Sciences

Waltham, MA

Full-time

Onsite

Senior Level

$154K/yr - $170K/yr

5+ years exp

Crescent Biopharma is focused on building a leading oncology company to advance transformative therapies for cancer patients. The Senior Scientist in Bioanalytical Sciences will manage bioanalytical activities for preclinical and clinical programs, ensuring data integrity and regulatory compliance while overseeing outsourced work and collaborating with internal teams and CROs.

BiotechnologyHealth CareMedical Device

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

Qualification

Bioanalytical technologyRegulatory complianceProject managementCRO managementDrug development practicesData-driven decision makingSmall molecule DMPKTeam collaboration

Required

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

Preferred

Small molecule DMPK experience is a plus

Benefits

100% employer-paid benefits package.

Flexible PTO.

Two, one-week company-wide shutdowns each year.

Medical, dental, vision, life insurance, short- and long-term disability.

Company’s savings plan (401(k)).

Long-term incentive program.

Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave.