15 days old

Scientist III, Manufacturing Sciences

Kelly Services
Pleasanton, CA 94588
Kelly is hiring a **Scientist III, Manufacturing Sciences** for one of our biotech clients in **Pleasanton, CA.**

+ Temp to perm (conversion after 90 days)

+ Pay: $32/hr

**_Scientist III, Manufacturing Sciences_**

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). At the Pleasanton site, 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 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 sites 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.

**_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 final reports

Hands-on experience supporting/implementing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities

Working knowledge 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

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-11-22 Expires: 2021-12-25

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Scientist III, Manufacturing Sciences

Kelly Services
Pleasanton, CA 94588

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