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Scientist I, Reagent Quality Control

Employer
PacBio
Location
Menlo Park, CA
Start date
Dec 1, 2023

View more

Discipline
Quality, Quality Control, Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Scientist I, Reagent Quality Control

Pacific Biosciences is seeking a driven, self-starter for the position of Reagent Quality Control (QC) Research Associate. In this role, the QC Chemist 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 SMRT sequencing technology. In addition, the individual will complete QC assay support 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:

QC:

  • 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/corrections of manufacturing/QC documentation (Batch Records, Work instructions, Test methods, etc.).
  • Data monitoring and trending of product quality.

New Product Development Support:

  • Work cross functionally with NPI Development to develop/validate new QC assays and specifications during transfer of new commercial products into Manufacturing Operations.
  • Complete stability studies for new commercial products.

ISO:

  • Work with QA team to identify gaps, develop solutions, and implement change.
  • Support validation and maintenance of existing QC equipment.

Position Requirements

  • Normally requires a PhD in a scientific discipline, or Masters 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, a plus.
  • Requires excellent verbal and written communication skills as well as the ability to work well with cross functional teams.
  • Excellent record keeping and writing skills for documenting and revising validation documents, stability documents, and manufacturing batch records/work instructions.
  • Experience with Batch Record automation (MES / electronic work instructions and data collection) for process manufacturing and batch production environment.
  • Computer proficiency - Word, Excel, PowerPoint, MS Project, Visio, ERP, MES.
  • Familiar with the use of Statistical Process Controls for Manufacturing.

Non-Field Based Employees are required to be onsite Monday-Thursday (Friday work from home). Depending on the role, some employees may be required to be 100% onsite.

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.

#LI-Onsite

Salary Range:

$97,400.00 - $146,200.00

Please be aware that, as a condition of employment, proof of COVID vaccination is required for all U.S.-based employees (subject to limited exceptions).

To ensure the health and safety of all PacBio employees and our prospective candidates, we have instituted a virtual interview experience.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications.


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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 650-521-8000, or http://careers@pacificbiosciences.com for assistance.

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