Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt 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.Summarized Purpose:Performs sophisticated laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and the industry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.Key responsibilities:
Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal direction.
Prepares study protocols, project status reports, final study reports and other project-related technical documents.
Communicates data and technical issues to the client and responds to client needs and questions.
Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
Assists with quality systems and new equipment.
Assists in crafting method validation or method transfer protocols and establish project timelines.
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 the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
Keys to SuccessEducation and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).Knowledge, Skills and Abilities:
Solid understanding and knowledge of general chemistry and separation science
Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA mentorship
Ability to utilize Microsoft Excel and Word to perform tasks
Proficiency on technical operating systems
Proven problem solving and troubleshooting abilities
Effective oral and written communication skills
Proven track record in technical writing skills
Time management and project management skills
Ability to work in a collaborative work environment with a team
Proven problem solving and troubleshooting abilities
Ability to train junior staff
BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.