Scientist III, Manufacturing Sciences
Company: Thermo Fisher Scientific
Posted on: January 6, 2022
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?
- 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
- 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
- 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
- Prepare and review completed and performed validation packages
by compiling and analyzing validation data for submittal for review
- 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.How
will you get here?
- 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
- Hands-on experience supporting/implementing IQ, OQ (IOQ)
equipment qualification related to various cleaning processes and
- Solid understanding of current FDA, IVDD and especially IVDR
- Understanding of cGMP regulation and quality management systems
for medical devices operations
- Strong communication and presentation skills, both oral and
- 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 playerOur 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 global
team of 90,000 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 at Thermo Fisher Scientific, where diverse
experiences, backgrounds and perspectives are valued.Apply today!
http://jobs.thermofisher.comThermo 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
AccessJob 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,
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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
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Keywords: Thermo Fisher Scientific, Pleasanton , Scientist III, Manufacturing Sciences, Other , Pleasanton, California
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