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17 days old

Scientist II

Kelly Services
Carlsbad, CA 92008
Kelly has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary position with a client that is seeking a **Scientist II in Carlsbad, CA. If interested/available, please reach out to Bryan Heffley directly at bryh262@kellyservices.com.**


PAY: $30-32/hr W2


DURATION: 12 months


LOCATION: On-site Carlsbad, CA


SCHEDULE: Mon Fri (1st shift)


**Job Description - Sci II, Plasmid Analysis**

We are looking for a talented QC Scientist II to join our QC-Analytical Services group to support in-process testing, release, and stability testing of plasmid drug substance and drug product for clinical and commercial supplies as per the applicable industry and company standards.


**Responsibilities:**

Perform testing for plasmid content, plasmid isoform quantitation, residual DNA, residual RNA, residual host cell proteins and final plasmid drug substance and drug product release testing.

Perform QC plasmid assay to support characterization, in-process, release, and stability of incoming cell banks and final products for the release and monitoring of plasmids, cell, and gene therapy products.

Take part in the investigation of non-conformance materials, corrective, and preventive actions.

Assist in the, revision, review of regulatory analytical procedures, validation/transfer protocols, work instructions, guidance, SOPs and generate reports as per the applicable regulatory and industry standards.

Work closely with R&D, manufacturing, quality, and project management teams to execute assays that meet customer and manufacturing needs in support of department, site, and corporate objectives.

Analyze data, present results, and conclusions to the team.

Assist the team in lab maintenance, ordering lab supplies and document management.

Responsible for lab management tasks and stability program. Train and supervise junior staff members.

Apply principles and practice of quality management systems to ensure work performed meets the applicable compliance and customer requirements.

Keep current on Environment, Health & Safety policies, ensure safe environmental and working conditions in the Analytical Sciences labs.

Use CE, real time PCR, ELISA, UV Spectrophotometry, agarose gel electrophoresis, SDS-PAGE, and other state of the art analytical tool to achieve project deliverable in a timely manner.

Other duties as assigned; travel as needed. Changes to individual responsibilities may occur due to business needs. Other duties that may be determined by the management.


**Education and Experience**

A Bachelors degree in Analytical Chemistry, Molecular Biology/Life Science (or closely related discipline). Preferred BS candidates with 3 + years experience, Masters degree with 2 + years of direct experience in a regulated biological and/or pharmaceutical industry

Experience in AcccuSeq, Empower Software, LIMS, SM, eDMS, TrackWise preferred. within a regulated biological and/or pharmaceutical industry

Knowledge of plasmid technology, cell biology, virology and or immunology is highly desirable.

Knowledge of USA 21 CFR, EudraLex, ICH, USP-NF, Ph. Eur, PDA, and ISPE, preferred.


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-02 Expires: 2022-06-02

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Scientist II

Kelly Services
Carlsbad, CA 92008

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