Bioanalytical Scientist

Orum Therapeutics • Lexington, MA

1d • Hybrid

About The Position

Orum Therapeutics is seeking a highly motivated and accomplished scientist to lead the Bioanalytical (BioA) and PK/PD function. This role is designed for a technical expert who thrives at the intersection of large and small molecule analysis, specifically focused on the complex characterization of Antibody-Drug Conjugates (ADCs). As a key scientific lead, you will orchestrate the bioanalytical lifecycle — from internal method innovation to global CRO oversight — ensuring high-quality data generation in a GLP/GCP environment. Beyond assay management, you will serve as a strategic partner in project teams, leveraging pharmacokinetic modeling to translate data into actionable insights that drive candidate selection and program progression.

Requirements

• Extensive experience in pharmacokinetic (PK) and biodistribution studies of Antibody-Drug Conjugates (ADCs), including application of advanced bioanalytical methods such as LC-MS/MS for small-molecule quantitation and MSD-based ligand-binding assays (LBAs).
• Proven track record in developing, validating, and implementing bioanalytical assays for ADC modalities, including total antibody, free and conjugated payload, and anti-drug antibodies (ADA) assays, in support of preclinical and clinical PK studies.
• In-depth understanding of ADME principles and drug discovery/development workflows, including screening strategies from early feasibility through candidate nomination.
• Experience in non-compartmental analysis of PK data, with hands-on experience in PK/PD modeling and simulation, population PK analysis, and meta-analysis is a plus.
• Working knowledge of GLP and GCP regulations and their application within bioanalytical and clinical study environments.
• Demonstrated ability to operate independently in fast-paced biotech settings while effectively collaborating within cross-functional, global teams.
• Excellent communication, organizational, and time-management skills, with the ability to manage multiple priorities and deliver high-quality results.
• Strong work ethic with a high degree of accountability, initiative, and ability to work with minimal supervision.
• Ph.D. or equivalent degree in Analytical Chemistry or a related field with a minimum of 5 years' experience.

Nice To Haves

• Experience in non-compartmental analysis of PK data, with hands-on experience in PK/PD modeling and simulation, population PK analysis, and meta-analysis is a plus.

Responsibilities

• Design and execute integrated Bioanalytical and PK/PD strategies for ADC programs, utilizing the three-analyte quantification approach (Total Ab, Conjugated, and Free Payload) from lead optimization to IND filing.
• Oversee in vitro and in vivo ADME studies, including payload metabolism, drug-drug interactions (DDI), and transporter assays, to define the metabolic fate of the ADC and the released payload.
• Provide high-level technical oversight for hybrid bioanalytical workflows, specifically bridging LBA and LC-MS/MS platforms to ensure robust quantification of complex modalities.
• Lead CRO selection and management, serving as the primary point of contact for method transfer, development, validation, and troubleshooting of proprietary assays under aggressive timelines.
• Review and approve SOPs, validation reports, and bioanalytical study plans in alignment with GLP/GCP standards and current FDA guidance.
• Act as the BioA/PK subject matter expert (SME) within multidisciplinary project teams, collaborating with Research & Development and Clinical teams to drive program milestones.
• Drive continuous improvement by evaluating emerging technologies to enhance the throughput and quality of ADC characterization.
• Execute an integrated role that bridges high-level scientific leadership and direct lab-based contributions, ensuring seamless translation from internal innovation to external CRO execution.
• Serve as the lead author for BioA and PK sections of regulatory submissions (IND/IB), ensuring full compliance with GLP/GCP and current FDA/EMA bioanalytical guidance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree