Work Schedule

Environmental Conditions

Job Description

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.

Discover Impactful Work:

As an ARS, you will routinely act as the project leader on multiple projects, interacts with clients, review and evaluate data, and write project reports. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.

Essential Functions:

• Acts as the principal investigator on studies.
• Prepares project status reports, final study reports and other project-related technical documentation.
• Reviews, interprets, and analyzes data for technical quality and compliance to protocols, methods, and SOPs. Participates in technical troubleshooting and reviews laboratory investigations and deviations. Leads investigations and Root Cause Analysis and proposes CAPAs.
• Organizes, schedules, and supervises laboratory resources for group's project activities and updates project status.
• Responds to client questions and needs, coordinates client communication
• Assists group leaders in their responsibilities.
• Assists in implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies.

• Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Independently performs and gives guidance on 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 for stability and analytical testing.
• Independently manages QC responsibilities. Communicates project status to project leader and helps to identify gaps and anticipates roadblocks in project team workflow.

Keys to Success:

Education

• Bachelor's degree (life sciences preferred) or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• 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, Abilities

• Solid understanding and knowledge of general chemistry. Background in general ELISA and immunochemistry principles preferred.
• Knowledge of laboratory requirements, PPD & client SOPs, ICH guidelines and FDA guidance. Ability to interpret and consider SOP and regulatory guidelines during study design activities
• Demonstrated proficiency on technical operating systems
• Proven leadership skills
• Ability to train and mentor junior staff
• Demonstrated ability to be project solution driven
• Good written and oral communication skills as well as presentation skills
• Ability to independently optimize analytical methods
• Project and time management skills

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.