Scientist I, Reagent Quality Control

Scientist I, Reagent Quality Control

PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems.  Our mission is to enable the promise of genomics to better human health. Genomics is core to all biological processes, and our advanced genomics tools provide scientists and clinical researchers the insights to better understand biology and health.  We are now entering the century of biology and genomics is at the heart of the next revolution.  Become part of the new paradigm in gene sequencing and help shape the future of genomic study by joining the PacBio team.

Position Summary: 
PacBio is seeking a driven, self-starter for the position of Reagent Quality Control (QC) Scientist. In this role, the QC Scientist is required to complete high quality work through QC assay execution from analytical assays (e.g., HPLC, fluorescent assays, etc.) to Use Test assays involving PacBio’s sequencing platforms. In addition, the individual will complete QC assay validation and transfer activities, execute stability studies, trend and interpret data, troubleshoot QC failures, and complete sustaining QC process improvements in the Reagent Manufacturing Organization. In this multi-faceted role, the ideal candidate is organized, independent, detailed oriented, process driven, quality driven, and skilled at problem solving.

Responsibilities:

• Perform DNA library preparations through Sequencing.
• Perform a variety of analytical assays including enzymatic assays.
• Ensure data integrity of production/QC documentation throughout product release.
• Work cross functionally with Manufacturing and QA groups to release product.
• Work with Development team to improve QC assay methods.
• Work with technical staff to investigate and troubleshoot QC failures.
• Support revisions of manufacturing and QC documentation (batch records, work instructions, test methods, validation documents, stability documents, etc.)
• Data monitoring and trending of product quality.
• Work cross functionally with NPI Development to develop and validate new QC assays and specifications during transfer of new commercial products into Manufacturing Operations.
• Complete stability studies for new commercial products.
• Work with QA team to identify gaps, develop solutions, and implement change.
• Support validation and maintenance of existing QC equipment.

Required Qualifications: 

• PhD in a scientific discipline, or Master’s with a minimum of 1-2 years of related experience or B.S. in a scientific discipline with a minimum of 4-6 years of related experience.
• Relevant industry experience in a Development or QC position.
• A proficient and motivated problem solver who strives for excellence.
• Ability to successfully multi-task with attention to detail within short deadlines.
• Prior experience in DNA library preparation and sequencing.
• Ability to work well individually and with cross functional teams.
• Computer proficiency - Word, Excel, PowerPoint, MS Project, Visio, ERP, MES.
• Familiar with the use of Statistical Process Controls for Manufacturing and statistical software.
• Excellent interpersonal, written, and verbal communication skills.

Preferred Experience: 

• Experience with Batch Record automation (MES / electronic work instructions and data collection) for process manufacturing and batch production environment.

You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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Salary Range:

$97,400.00 - $146,200.00

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