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Associate Scientist (Pharmacokinetics) – Biologics

Job Title: Associate Scientist (Pharmacokinetics) – Biologics

Location: 760 Pennsylvania Dr, Exton, PA 19341

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Job Summary: We are seeking a highly motivated and detail-oriented Associate Scientist to join our Pharmacokinetics (PK) group. The successful candidate will support bioanalytical method development, validation, and sample analysis using ligand binding assays (LBA) to assess pharmacokinetics for preclinical and clinical studies. This role requires expertise in bioanalytical techniques, data analysis, and regulatory compliance.

Key Responsibilities:

• Develop, optimize, and validate ligand binding assays (e.g., ELISA, MSD, Gyrolab) for quantifying therapeutic molecules in PK studies.
• Perform routine bioanalysis of preclinical and clinical samples under GLP and non-GLP conditions.
• Analyze and interpret experimental data, ensuring accuracy, reproducibility, and regulatory compliance.
• Troubleshoot and resolve technical issues related to assay performance and instrumentation.
• Maintain detailed and organized records of experimental procedures and results in laboratory notebooks and electronic systems.
• Contribute to the preparation of bioanalytical reports, method validation reports, and regulatory submissions.
• Collaborate with pharmacokinetics, toxicology, clinical, and regulatory teams to support drug development programs.
• Ensure compliance with regulatory guidelines (GLP, FDA, EMA) and company policies for bioanalytical studies.

Qualifications:

• Bachelor’s or master’s degree in Biochemistry, Molecular Biology, Immunology, Pharmaceutical Sciences, or a related field.
• Entry-level candidates, including recent graduates, are encouraged to apply. Hands-on experience in ligand binding assay development, validation, and sample analysis through coursework, internships, or research projects is a plus.
• Familiarity with bioanalytical techniques such as ELISA, MSD, and Gyrolab.
• Knowledge of pharmacokinetics, immunogenicity assessment, and bioanalytical regulatory requirements.
• Experience in a GLP-compliant environment is a plus.
• Strong analytical and problem-solving skills with the ability to troubleshoot assay performance issues.
• Excellent organizational skills and attention to detail.
• Effective communication and teamwork skills to collaborate with multidisciplinary teams.

Preferred Qualifications:

• Experience with automated liquid handling systems for bioanalysis is a plus; training opportunities will be provided for candidates eager to learn automation.
• Proficient in coding language for data analysis and automation (e.g., Python, Kotlin).
• Familiarity with software for data analysis (e.g., SoftMax Pro, Watson LIMS, GraphPad Prism).
• Understanding of regulatory expectations for bioanalytical method validation (FDA, EMA, ICH guidelines).
• Bilingual (Mandarin/English) preferred.

Why Join Us?

• Be part of a collaborative and innovative bioanalytical team supporting groundbreaking drug development.
• Gain exposure to cutting-edge bioanalytical techniques and regulatory-driven workflows.
• Opportunity for career growth within a dynamic and fast-paced research environment.

If you are passionate about bioanalysis and eager to contribute to the development of novel therapeutics, we encourage you to apply for this exciting opportunity.

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.