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1+ months

Scientist III

Kelly Services
Carlsbad, CA 92008
**Kelly Services is actively recruiting for a Direct Hire opportunity in** **Carlsbad** **, CA for a** **Scientist** **.**


We are looking for a talented Scientist III to join our QC Analytical Chemistry group to support Sanger Sequencing and next-generation sequencing (NGS) regulatory analytical procedures development, validation, transfer, verification, and execution of cell-based and nucleic acid-based, cell and gene therapy, and mRNA-based products and vaccines for clinical and commercial supplies as per the applicable industry and company standards.

This role is for a Scientist interested in joining a fast-growing team of professionals that provides excellent professional and personal growth and development opportunities.


What will you do?

As a QC Scientist, independently perform the development, validation, transfer, and verification of ID, by Sanger Sequencing Method / by New Generation Sequencing (NGS) Method of host cell, final plasmid drug substance, and drug product.

Perform ID Assay by Sanger Sequencing Method for the release of Cell Banks, Bulk Drug Substance, Drug Products and Stability Monitoring.

Perform ID Assay and Purity by NGS Method for the release of Cell Banks, Bulk Drug Substance, Drug Products and Stability Monitoring.

Perform characterization and monitoring studies by NGS/Sanger Sequencing methods.

Perform investigation of non-conformance materials, recommend corrective and preventive actions in a timely manner.

Independently develop, revise, review regulatory analytical procedures, validation/transfer protocols, work instructions, guidance, SOPs and generate repots 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.

Independently analyze data, present results, and conclusions to the team.

Identify areas for further innovation and support continuous improvement efforts (e.g., improved sensitivity, reduced turnaround time, assists in delivering cost effective quality products).

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

Apply principles and practice of quality improvement.

Experience in one or more analytical procedures e.g. plasmid topology be CE, real time PCR (residual DNA/RNA), Host Cell Proteins by ELISA, UV Spectrophotometry, agarose gel electrophoresis, SDS-PAGE, is preferred.

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

Generate, review, and revise 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.


Education

Bachelors degree in Analytical Chemistry, Life Sciences or Chemical/Biological Engineering (or closely related field); Masters/PhD preferred

3-4+ years direct experience in a regulated biological and/or pharmaceutical industry required; 5-7+ years preferred, or equivalent combination of education and experience


Experience:


Experience in a regulated biological and/or pharmaceutical industry, preferred.

Demonstrated hands on experience in Sanger Sequencing methodologies.

Demonstrated hands on experience in NGS methodologies.

Experience in Capillary Electrophoresis using SCIEX 800 Plus or HPLC with Empower Software, Preferred.


Knowledge, Skills, Abilities

Basic knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment.

Knowledge of AcccuSeq, Empower Software, LIMS, SM, eDMS, TrackWise within a regulated biological and/or pharmaceutical industry, preferred

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

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

Ability to use Microsoft Excel, Word, Power Point, or other planning tools

Strong interpersonal and self-management skills

Attention to detail skills

Strong customer service orientation


**APPLY NOW!**


\#TJP2022_SPEC


**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: 2022-07-11 Expires: 2022-08-18

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Scientist III

Kelly Services
Carlsbad, CA 92008

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