Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

• Laboratory Setting, Office
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• Will work with hazardous/toxic materials

About the Role

This is a fully onsite role based in our bioanalytical laboratory at 8700 Quioccasin Road in Richmond, VA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Responsibilities

• Independently perform and oversee a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices
• Review and compile results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications
• Coordinate and supervise laboratory activities of other team members in conjunction with the lab supervisor
• Lead study design and protocol authoring
• Lead data evaluation and study close-out
• Provide advanced technical guidance and mentorship to junior and senior scientists
• Develop and optimize new analytical methods and procedures
• Manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
• Act as a primary point of contact for client interactions and project updates
• Train on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines
• Complete all laboratory documentation in clear and accurate language and according to SOP and GLPs
• Lead advanced troubleshooting for various equipment & instruments
• Review and compile results from assignments and make determination on acceptability per SOP acceptance criteria
• Review overall study results
• Navigate the OOS/OOT/Atypical investigation process
• Lead more complex investigations and Root Cause Analysis and lead CAPAs
• Independently manage QC responsibilities
• Communicate project status to project leader and help address gaps and solutions to overcoming roadblocks in project team workflow
• May act as project leader
• Perform study design & protocol authoring
• Independently complete QA facing tasks
• Author and lead more complex quality records
• Mentor other staff members in applicable areas

A Day in the Life

You will train on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines. You will independently perform and give guidance on a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing. You will complete all laboratory documentation in clear and accurate language and according to SOP and GLPs. You will lead advanced troubleshooting for various equipment & instruments, review and compile results from assignments, and make determination on acceptability per SOP acceptance criteria. You will review overall study results and navigate the OOS/OOT/Atypical investigation process. You will lead more complex investigations and Root Cause Analysis and lead CAPAs, independently manage QC responsibilities, and communicate project status to project leaders. You will coordinate and supervise laboratory activities of other team members in conjunction with lab management, perform study design & protocol authoring, lead data evaluation and study close-out, and independently complete QA facing tasks.

Qualifications

Required Education and Experience

• BS and eight years of experience, OR
• MS and six years of experience, OR
• PhD and four years of experience

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Intermediate knowledge of relevant scientific principles applicable to role, ideally seeking candidates with LCMS and biological matrices experience
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and regulatory guidance
• Full knowledge of technical operating systems
• Ability to independently optimize analytical methods
• Ability to independently perform root cause analysis for quality records
• Proven technical writing skills
• Proven problem solving and troubleshooting abilities
• Effective written and oral communication skills as well as presentation skills
• Time management and project management skills
• Ability to mentor others on technical operating systems
• Ability to independently review and understand project proposals/plans
• Ability to work in a collaborative work environment with a team

Requirements

• Must be legally authorized to work in the United States without sponsorship
• Must be able to pass a comprehensive background check, which includes a drug screening

Working Conditions and Environment

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment
• Occasional drives to site locations, occasional domestic travel
• Exposure to biological fluids with potential exposure to infectious organisms
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste
• Personal protective equipment required such as protective eyewear, garments and gloves
• Exposure to fluctuating and/or extreme temperatures on rare occasions

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.