Associate Principal Scientist, Regulated Bioanalytics (Pharmacokinetics) Full-time

Associate Principal Scientist In Regulated Bioanalytics

We are recruiting for an Associate Principal Scientist in Regulated Bioanalytics to serve as an advanced technical contributor responsible for the development, validation, and implementation of regulated bioanalytical methods to support quantitative analysis of therapeutic and biotherapeutic drug candidates.

Job Summary:

• Provide technical leadership and sound regulatory judgment for bioanalytical assay development, qualification, validation, and sample analysis in compliance with applicable regulatory guidance and Good Laboratory Practice (GLP).
• Independently manage bioanalytical responsibilities for assigned development programs, including defining technical approaches, ensuring data quality and integrity, and meeting program timelines.
• Apply deep technical expertise to troubleshoot and resolve complex bioanalytical challenges, including those associated with novel or emerging drug modalities.
• Author, review, and contribute to high‑quality regulatory documentation and critical technical reports supporting preclinical and clinical development and regulatory submissions.
• Communicate complex scientific findings and recommendations effectively to cross‑functional colleagues and external collaborators to support informed decision‑making.
• Contribute to continuous improvement within the bioanalytical function through adoption of best practices, process optimization, and effective knowledge sharing.
• Serve as a technical mentor to junior scientists and a subject matter expert within regulated bioanalysis.

Key Responsibilities:

• Support late‑stage drug development activities, including bioanalytical readiness for pivotal studies and regulatory submissions.
• Demonstrate advanced expertise in regulated bioanalytical methods for quantifying therapeutic and biotherapeutic drug candidates and anti‑drug antibodies, using ligand‑binding assay–based platforms (e.g., Meso Scale Discovery, Gyrolab, Ella), LC‑MS methodologies, and emerging bioanalytical technologies.
• Provide scientific leadership and sound regulatory judgment for internal and external bioanalytical assay development, qualification, validation, and sample analysis in support of preclinical and clinical studies.
• Independently apply deep technical knowledge to adapt and extend established bioanalytical methodologies to address challenges in complex biological matrices and evolving development programs.
• Contribute to innovation by developing and implementing new approaches, hypotheses, or process improvements to address bioanalytical challenges associated with emerging and complex drug modalities.
• Author, review, and contribute to high‑quality regulatory documentation (e.g., IND‑ and BLA‑supporting modules), internal technical reports, and responses to regulatory questions.
• Effectively communicate complex scientific concepts and influences stakeholders, fostering informed decision‑making and, when appropriate, encouraging alternative perspectives through collaboration and scientific contribution.
• Strong organizational and project management skills to oversee multiple studies simultaneously.

Qualifications:

Education:

• Bachelor's (with 10+ years), Master's (with 6+ years) or Ph.D. (with 4+ years) in Chemistry, Analytical Chemistry, Molecular Biology, Immunology, Cell Biology, Biology, Biochemistry or a related Biological Sciences discipline and relevant experience.

Required Experience and Skills:

• Advanced experience in regulated bioanalysis for PK and/or immunogenicity, including developing, qualifying, and validating ligand-binding and/or LC–MS assays.
• Strong knowledge of global regulatory expectations, including writing and reviewing documents for IND/BLA submissions.
• Ability to lead bioanalytical strategy for development programs, delivering high-quality data on time.
• Experience troubleshooting complex bioanalytical issues and adapting methods for challenging matrices and changing program needs.
• Clear scientific writing and communication skills to present data, interpret results, and support cross-functional decisions.
• Strong project management skills to run multiple studies and priorities in a fast-paced environment.

Preferred Experience and Skills:

• Deep immunogenicity (ADA) experience, including assay design, validation strategy, and clinical data interpretation.
• Experience supporting bioanalytical strategy for complex and emerging modalities (e.g., peptides, multispecific antibodies, and other novel therapeutics).
• Hands-on experience across platforms (e.g., Meso Scale Discovery platform, Gyrolab, LC–MS), including choosing fit-for-purpose approaches and driving method/process improvements.
• Strong cross-functional leadership, including mentoring junior scientists and building best practices.