Bioanalytical Scientist LC-MS/MS

Pharmaron • Germantown, MD

2d • $85,000 - $93,000

About The Position

The Bioanalytical Scientist LC-MS Bioanalysis, SMB performs laboratory-based activities, including data processing and review, within established timelines and in accordance with Standard Operating Procedures (SOPs) and company policies. The role supports efficient laboratory operations through routine laboratory and equipment maintenance and fosters positive, professional working relationships across teams and organizational levels. The position may serve as Lead Scientist/Principal Investigator (PI) and primary point of contact for sponsors.

The role includes core bioanalytical responsibilities and additional duties that vary by level. Bioanalytical Scientist I duties include preparing data tables and reports in Watson™ LIMS, supporting data transfers and preclinical and clinical data management, coordinating procurement of study materials, supporting responses to QA audit findings, onboarding and training new hires, and potentially managing Associate Bioanalytical Scientists. Bioanalytical Scientist II may assume Lead Scientist/PI responsibilities, including sponsor communications, study planning and oversight, document review, coordination across study teams, documentation and archiving, business development support, and participation in scientific conferences.

Requirements

• For Bioanalytical Scientist I: PhD in a relevant field with at least 0–1 year of experience, or Master of Science in a relevant field with at least 2–3 years of relevant experience, or Bachelor of Science in a relevant field with at least 4 years of relevant experience.
• For Bioanalytical Scientist II: PhD in a relevant field with at least 1–2 years of experience, or Master of Science in a relevant field with at least 3–4 years of relevant experience, or Bachelor of Science in a relevant field with at least 5 years of relevant experience.
• Knowledge of FDA bioanalytical method validation guidance and applicable regulatory requirements.

Nice To Haves

• Knowledge of clinical trial conduct.
• Strong interpersonal and client management skills.
• Working knowledge of project management processes.

Responsibilities

• Collaborate with Lead Scientists to execute LC-MS/MS assay development, validation, and sample analysis in accordance with study requirements and applicable regulatory guidance.
• Maintain compliance with laboratory safety policies, company SOPs, and study-specific plans, including completing and self-reviewing required training documentation and refresher training.
• Support staff training, mentoring, and technical development as needed.
• Oversee assigned laboratory equipment scheduling, maintenance, and calibration.
• Develop and review SOPs and contribute to departmental process improvements.
• Apply knowledge of FDA bioanalytical method validation guidance and applicable regulatory requirements.
• Prepare data tables and reports in Watson™ LIMS and support data transfers and preclinical and clinical data management activities.
• Coordinate procurement of reference materials, control plasma, and study-specific consumables.
• Support responses to Quality Assurance (QA) audit findings.
• Support onboarding and initial training of new hires.
• May serve as a line manager for Associate Bioanalytical Scientists.
• Serve as primary sponsor contact for assigned studies, lead client communications, and provide updates on study progress and deliverables.
• Plan and oversee study execution, including experimental design, data interpretation, and preparation, review, and finalization of study reports.
• Review study-related documents, including laboratory manuals, clinical protocols, and data transfer agreements.
• Coordinate with sample management, report writing, and QA teams to ensure appropriate sample handling, report completion, audit readiness, and resolution of study findings.
• Oversee study documentation and archiving, including correspondence and electronic raw data.
• Provide scientific and technical support for business development activities, including client visits.
• Participate in and present at scientific conferences.

Benefits

• Comprehensive medical, dental, and vision insurance with significant employer contributions.
• 401(k) retirement plan with generous employer matching.
• Paid time off, paid sick leave, and company holidays.
• Employer-funded Health Savings Account contributions for eligible plans, plus healthcare and dependent care Flexible Spending Accounts.
• 100% employer-paid employee life insurance, AD&D, and short- and long-term disability insurance.
• Employee Assistance Program, mental health resources, and wellness programs.
• Family-friendly benefits, including fertility support and maternity resources.
• Professional development and career growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level