PK​/ADA Scientist

Location: Auxvasse

Job Title:

PK/ADA Scientist

Job Description

The PK/ADA Scientist plays a key role in ensuring the scientific integrity and quality of bioanalytical studies focused on pharmacokinetics (PK) and anti-drug antibody (ADA) analysis. This position autonomously develops, plans, manages, conducts, reports, and troubleshoots multiple assay types to meet scientific and regulatory expectations while driving client satisfaction. The Scientist may serve as the primary laboratory contact for assigned projects, overseeing method development, validation, and sample analysis for clinical and non-clinical studies in a regulated bioanalytical environment.

Responsibilities

+ Develop, plan, manage, conduct, and troubleshoot multiple PK and ADA assay types to ensure high scientific quality and compliance with regulatory expectations.

+ Serve as Bioanalytical Principal Investigator for validations and sample analysis, acting as the first point of contact for project management and clients for laboratory services.

+ Manage and conduct method development, qualification, validation, and production studies for clinical and non-clinical programs in compliance with protocols, study plans, amendments, GCP, GLP, SOPs, and best practices.

+ Manage assigned projects and proactively order and coordinate appropriate materials and resources as needed to support study timelines.

+ Provide quality control support on studies assigned to other team members, based on training and competencies, to maintain data integrity and consistency.

+ Perform data batch review and multi-batch trend analysis, ensuring accurate documentation of deviations, events, and non-compliance, and review or approve Memos to File and SOP/Protocol/Study Plan deviations.

+ Prepare and deliver clear, accurate study reports and result summaries within agreed timelines, ensuring that all analyses and any deviations or exception events are appropriately documented.

+ Maintain project timelines and scheduling commitments, proactively identifying and resolving issues that could impact study delivery.

+ Review and provide comments and recommendations on bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and other relevant documents as needed.

+ Support and mentor Analysts in daily operations related to sample analysis and validation studies, guiding their work and promoting best practices.

+ Support and mentor other team members based on scientific expertise, fostering knowledge sharing and continuous improvement.

+ Troubleshoot technical and scientific issues within studies and independently develop appropriate procedures to resolve them.

+ Organize, analyze, and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds.

+ Write, review, and update method-specific SOPs as needed to reflect current practices and regulatory requirements.

+ Participate in client meetings, scientific conferences, and outreach activities to represent the laboratory's scientific capabilities and expertise.

+ Conduct all work in strict compliance with applicable SOPs, GCPs, GLPs, ICH guidelines, and internal policies.

+ Respect and follow health and safety standards, including personal protection, laboratory maintenance, and safe work procedures.

Essential Skills

+ 2-5 years of hands-on experience with either PK or ADA in a regulated bioanalytical or CRO setting.

+ Minimum 3 years of experience in a preclinical or contract research organization environment.

+ PhD or MS degree in Chemistry, Biochemistry, Immunology, or a related scientific discipline.

+ PhD with at least 2 years of experience with ADA or PK, or MS degree with at least 4 years of experience with ADA or PK.

+ Proven experience in a preclinical/CRO environment working under GLP and ICH guidelines.

+ Strong practical experience with ELISA assays and MSD-ECLA (MSD platform) for biomarker and large molecule analysis.

+ Demonstrated experience developing PK or ADA assays from scratch, including method development and validation.

+ In-depth knowledge of regulatory agency guidelines, general SOPs, and excellent understanding of GLP regulations.

+ Ability to read, interpret, and apply study plans, protocols, and laboratory manuals accurately.

+ Excellent troubleshooting skills for resolving scientific, technical, and procedural issues within studies.

+ Strong organizational skills with the ability to manage multiple projects and timelines simultaneously.

+ High level of attention to detail and commitment to data integrity and documentation accuracy.

+ Client-oriented mindset with strong communication skills for interacting with project managers and external stakeholders.

+ Ability to coach, mentor, and support analysts and team members in daily laboratory operations.

+ Flexibility and a strong sense of urgency, with the ability to adapt to changing priorities in a fast-paced environment.

Additional

Skills & Qualifications

+ College or university degree in Chemistry,…