Work Schedule
Standard (Mon-Fri)Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory SettingJob 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:
Independently perform bioanalytical method development, optimization, validation, and method transfers for pharmaceutical and biopharmaceutical compounds. Expertise in molecular genomics, cell and gene therapy, including nucleic acid purification, qPCR, rt-qPCR, ddPCR, and dPCR. Design and execute experiments independently for both themselves and others. Help onboard new instrumentation, set up the lab, and initiate contracted development work, including setting up and testing IT systems, analysis systems, and electronic notebooks.
A day in the Life:
- Writes, reviews and critiques study protocols, project status reports, final study
- reports and other project-related technical documents.
- Leads analytical (procedural and instrumental) troubleshooting sessions.
- Assists business development group in technical sales and marketing, and presents posters at technical conferences.
- Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
- 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.
Qualifications:
Education and Experience:
- PhD, masters or 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 8+ years).
Knowledge, Skills and Abilities:
- Intermediate knowledge of molecular genomics assay development, qualification and validation including DNA and RNA handling, extraction, and analysis
- Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA
- guidance
- Full knowledge of technical operating systems
- Ability to independently optimize analytical methods
- Ability to independently perform root cause analysis for method investigations
- 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
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! http://jobs.thermofisher.com
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.
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