Research Scientist - Container Closure Integrity Testing
About The Position
At Thermo Fisher Scientific, the mission is to enable customers to make the world healthier, cleaner, and safer. The company supports individual career goals and advances science through research, development, and delivery of life-changing therapies. Clinical trials are conducted in over 100 countries, utilizing laboratory, digital, and decentralized clinical trial services through the PPD clinical research portfolio. The PPD® Laboratory Services team focuses on improving patient health through the expertise of scientists, industry thought-leaders, and therapeutic experts, delivering groundbreaking innovations with a commitment to accuracy and quality. This role involves possessing a thorough understanding of laboratory procedures and reliably conducting complex analysis with increased independence.
Requirements
- PhD with 4+ years of experience; OR MS degree with 7+ years of experience; OR BS degree with 8+ years of experience
- Proficient in Microsoft Excel and Word
- Proven ability to interpret data by performing trend analysis
- Proven ability in technical writing skills
- Ability to independently optimize analytical methods
- Proven problem solving and troubleshooting abilities
- Good written and oral communication skills
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
- Skilled at written and verbal communication, documenting and sharing experimental methods, data, outcomes, and conclusions to diverse audiences
- Ability to identify issues and adapt experiments on-the-fly, a skill facilitated by strong attention to detail and a willingness to ask for help
- Skilled at prioritization and navigating ambiguity with a positive demeanor
Nice To Haves
- Previous GMP experience preferred
- Previous experience with cell based bioassays
Responsibilities
- Conduct complex analysis with increased independence
- Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices
- Follow validated or experimental analytical procedures with periodic direct supervision
- Review and compile results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications
- Enter data into databases and reports
- Perform self-review for own data prior to QC submission
- Independently perform method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems
- Understand and conform to methods and protocols applicable to assigned tasks
- Design and drive experiments with minimal supervision
- Prepare study protocols, project status reports, final study reports and other project-related technical documents
- Communicate data and technical issues to the client and respond to client needs and questions
- Mentor, train and coordinate laboratory activities of other team members and assist in troubleshooting instrument and analytical problems
- Assist with quality systems and new equipment
- Assist in designing method validation or method transfer protocols and establish project timelines
- Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)
- Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
