Job Description
*Work Schedule*
Standard (Mon-Fri)*Environmental Conditions*
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)*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.
- 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 Success* *Education and Experience:*
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous 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
- Benefits* We 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!
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. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! [ 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.
Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Job Tags