Entry-Level Bioanalytical Scientist, Pharmacokinetics, Onsite

An entry-level scientific position supporting the development, qualification, validation, and application of bioanalytical methods to quantify drug candidates and metabolites in biological matrices. This role offers the opportunity to develop technical expertise in regulated bioanalysis within a collaborative, multidisciplinary environment operating under GLP and GxP standards.

Responsibilities

• Conduct routine laboratory experiments supporting bioanalytical method development, qualification, validation, and sample analysis.
• Perform sample preparation, data acquisition, data review, and interpretation using established analytical platforms.
• Maintain accurate laboratory records, electronic notebooks, and study documentation in compliance with regulatory requirements.
• Assist in the preparation of study protocols, validation reports, study reports, and other regulatory documentation.
• Participate in troubleshooting analytical methods, instrumentation, and laboratory processes.
• Collaborate with scientists, project teams, quality organizations, and program stakeholders to ensure timely delivery of scientific data.
• Follow all company safety, environmental, and quality requirements.
• Contribute to laboratory operational excellence initiatives, including automation, process improvements, and continuous improvement projects.
• Communicate scientific findings effectively through presentations, technical summaries, and team discussions.

Requirements

• Bachelor's Degree in Biology, Biochemistry, Chemistry, Pharmaceutical Sciences, Immunology, Molecular Biology, or another related scientific discipline.
• Demonstrated laboratory experience through academic research, internships, co-op placements, or industry experience.
• Strong analytical and problem-solving skills.
• Ability to carefully follow experimental procedures and document work accurately.
• Effective written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to work both independently and collaboratively within a team environment.

Preferred Qualifications

• Experience with regulated bioanalysis, GLP, Good Manufacturing Processes (GMP), or GxP environments.
• Hands-on experience with ligand binding assays, cell-based assays, Liquid Chromatography-Mass Spectrometry (LC-MS/MS), or automated laboratory platforms.
• Familiarity with biological sample handling and immunogenicity testing.
• Knowledge of FDA, EMA, and ICH bioanalytical method validation guidance.
• Experience with scientific data analysis and reporting software.

Key Success Factors

• Demonstrates a strong learning mindset and willingness to develop scientific expertise.
• Embraces feedback and continuously improves technical and professional skills.
• Maintains a high standard of scientific integrity and data quality.
• Prioritizes safety, compliance, and teamwork.
• Shows adaptability and curiosity in addressing scientific and operational challenges.

Skills

• Required: Adaptability, Clinical Research, Communication, Compliance Frameworks, Compliance Reporting, Data Analysis, Data Governance, Data Reporting, Project Coordination, Records Management, Stakeholder Relationship Management, Teamwork.
• Preferred: Experience with current bioanalytical technologies and regulatory environments.

Pay

The salary range for this role is $71,900.00 - $113,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

Schedule

• Shift: 1st - Day.
• Travel Requirements: 10%.