Bioanalytical Scientist LC-MS/MS

Pharmaron • Germantown, MD

7d • Onsite

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 scientist may serve as Lead Scientist/Principal Investigator (PI) and primary point of contact for sponsors.

Core responsibilities include collaborating with Lead Scientists on LC-MS/MS assay development, validation, and sample analysis; maintaining compliance with safety policies, SOPs, study plans, and required training; supporting staff training and development; overseeing assigned equipment scheduling, maintenance, and calibration; developing and reviewing SOPs; and contributing to process improvements. The position applies knowledge of FDA bioanalytical method validation guidance and applicable regulatory requirements.

For Bioanalytical Scientist I, additional duties include preparing data tables and reports in Watson™ LIMS, supporting data transfers and preclinical and clinical data management, coordinating procurement of reference materials and study consumables, supporting responses to QA audit findings, and assisting with new-hire onboarding and training. The role may include line management of Associate Bioanalytical Scientists.

For Bioanalytical Scientist II, the position may also take on Lead Scientist/PI responsibilities, including serving as the primary sponsor contact, leading client communications, planning and overseeing study execution, interpreting data, and preparing and finalizing study reports. Additional duties include reviewing study documents, coordinating with sample management, report writing, and QA teams, overseeing documentation and archiving, supporting business development and client visits, and participating in and presenting at scientific conferences.

Requirements

• Bioanalytical Scientist I: PhD in a relevant field and at least 0–1 year of experience, or a Master of Science in a relevant field and at least 2–3 years of relevant experience, or a Bachelor of Science in a relevant field and at least 4 years of relevant experience.
• Bioanalytical Scientist II: PhD in a relevant field and at least 1–2 years of experience, or a Master of Science in a relevant field and at least 3–4 years of relevant experience, or a Bachelor of Science in a relevant field and at least 5 years of relevant experience.

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, study-specific plans, and required training documentation.
• 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 (Bioanalytical Scientist I).
• Coordinate procurement of reference materials, control plasma, and study-specific consumables (Bioanalytical Scientist I).
• Support responses to Quality Assurance (QA) audit findings and assist with onboarding and initial training of new hires (Bioanalytical Scientist I).
• May serve as a line manager for Associate Bioanalytical Scientists (Bioanalytical Scientist I).
• Serve as the primary sponsor contact for assigned studies, lead client communications, and provide updates on study progress and deliverables (Bioanalytical Scientist II/PI duties).
• Plan and oversee study execution, including experimental design, data interpretation, and preparation, review, and finalization of study reports (Bioanalytical Scientist II/PI duties).
• Review study-related documents, including laboratory manuals, clinical protocols, and data transfer agreements (Bioanalytical Scientist II/PI duties).
• Coordinate with sample management, report writing, and QA teams to support sample handling, report completion, audit readiness, and resolution of study findings (Bioanalytical Scientist II/PI duties).
• Oversee study documentation and archiving, including correspondence and electronic raw data (Bioanalytical Scientist II/PI duties).
• Provide scientific and technical support for business development activities, including client visits, and participate in and present at scientific conferences (Bioanalytical Scientist II/PI duties).

Benefits

• Comprehensive medical, dental, and vision insurance with significant employer contributions.
• 401(k) retirement plan with 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.
• 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