Employer Active
Job Alert
You will be updated with latest job alerts via emailJob Alert
You will be updated with latest job alerts via emailWork Schedule
Standard (Mon-Fri)Environmental Conditions
Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
At Thermo Fisher Scientific youll 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.
Responsible for the regulatory and scientific conduct of development validation stability projects and/orother specialty technologies such as extractable/leachable studies. Performs troubleshooting on multiple
analytical instrumentation (HPLC GC UPLC ICP-MS LC/MS GC/MS etc.) and multiple detectiontechniques (UV FL CAD ELSD IC etc.) calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely acts as thetechnical project leader for multiple projects interacts with clients on a weekly basis (or as needed) toprovide updates reviews and evaluates data writes reports and protocols.
Independently performs analytical testing method optimization/validation
and/or other specialty technologies studies OR method transfers forpharmaceutical and biopharmaceutical compounds in a variety of formulationsand/or delivery systems. Understands and conforms to methods and protocolsapplicable to assigned tasks. Designs and executes experiments independently.
Reviews and critiques study protocols project status reports final study reportsand other project-related technical documents.
Prepares and reviews study protocols project status reports final study reportsand other project-related technical documents.
Communicates data and technical issues to clients on a weekly basis (or as
needed).
Provides technical guidance and training to staff.
Leads analytical (procedural and instrumental) troubleshooting sessions.
Assists in preparation and implementation of SOPs and quality systems.
Reviews interprets and analyzes data for technical quality and compliance to
protocols methods SOPs client criteria and Good Manufacturing Practices
(GMP) or Good Laboratory Practices (GLP). Performs self and peer review of thedata for accuracy and compliance with reporting requirements prior to
submission to QA and issuance to customers.
Knowledge Skills and Abilities:
Knowledge of general chemistry and separation science
Ability to independently perform root cause analysis for method investigations
Proficiency on technical operating systems
Proven problem solving and troubleshooting abilities
Proven ability in technical writing skills
Time management and project management skills
Good written and oral communication skills
Ability to work in a collaborative work environment with a team
Ability to train junior staff
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:
Required Experience:
IC
Full-Time