As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
This Scientist III Analytical Chemistry position is available at the Pleasanton site (CA) within the Genetic Sciences division unit of Thermo Fisher Scientific's Life Sciences Solutions Group (LSG). We make oligos and small molecules that have uses from research to disease diagnosis and recently therapeutics. The successful candidate will be developing analytical methods and supporting manufacturing teams to investigate and troubleshoot manufacturing processes as required. Additional responsibility includes planning and execution of onsite cleaning validation programs aligned with regulatory requirements.What will you do?
How will you get here?
- Develop analytical methods for identifying and quantifying oligonucleotides in a given sample or sample mixtures.
- Design, plan and implement experiments to evaluate the performance of chromatography and mass spectrometry consumables.
- Build cleaning cycle development strategies for a variety of equipment used for the manufacturing processes.
- Assist with the creation/revision of IVDR procedures, forms and templates.
- Monitors and interprets IVDR regulations and guidelines and interacts with project teams to provide guidance to complete deliverables per established deadlines
- Write validation protocols and reports in support of the site's cleaning and analytical validation program
- Perform risk assessment and gap analysis for site cleaning programs.
- Prepare and review completed and performed validation packages by compiling and analyzing validation data for submittal for review and approval
- Maintain up-to-date knowledge of validation requirements, practices, and procedures
- Leads continuous improvement activities related to analytical methods as well as cleaning & changeover optimization.
- Responsible for identifying appropriate cleaning/sanitizing agents; participates in cleaning/sanitizing efficiency studies.
- B.Sc degree in Chemistry, Biochemistry, or a related-discipline and 2+ years industrial experience.
- Experience in using LCMS/UHPLC/UV-Vis absorption spectroscopy/fluorescence spectroscopy is required.
- Preference will be given to candidates with analytical experience in the area of oligonucleotide and small molecule chemistry.
Knowledge, Skills, Abilities
- Proven understanding of reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
- Hands-on experience supporting/implementing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities
- Solid understanding of current FDA, IVDD and especially IVDR regulations.
- Understanding of cGMP regulation and quality management systems for medical devices operations
- Strong communication and presentation skills, both oral and written
- Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
- Must have a strong ability to prioritize and manage multiple tasks in a fast-paced environment.
- Capable of multi-tasking and having strong time-management skills to meet a demanding work schedule is needed
- Participate as a team player
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