Senior Scientist, Reagent QC

Location
Menlo Park, CA, United States
Posted
Mar 03, 2021
Ref
2140
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Senior Scientist, Reagent QC

Pacific Biosciences is seeking a driven, self-starter for the position of Reagent Quality Control (QC) Senior Scientist. In this role, the Senior 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 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


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.

Position Requirements
  • Bachelors or Masters+ degree in Molecular Biology, Biochemistry, or related discipline
  • 2+ years of 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


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.