Senior Scientist, Reagent Process Development

Location
Menlo Park, CA, United States
Posted
May 23, 2021
Ref
2231
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Senior Scientist, Reagent Process Development

Pacific Biosciences is seeking a driven Senior Scientist, Reagent Process Development, to develop commercial reagent products for our SMRT Sequencing system. In this position, the person will work closely with the R&D team(s) in demonstrating feasibility, generating product specifications, characterizing the product, developing manufacturing and QC processes, and transferring these stable processes to Manufacturing.

The Senior Scientist will lead the development of reagents qualification methods, quality control protocols, develop strategies for formulation optimization and kitting. S/he will provide technical expertise to the new product introduction and will characterize reagents to meet manufacturing requirements for critical reagent consumables. Candidate should have strong hands-on laboratory experience, including reagent formulations, sample preparation, analytical assay development and preferably sequencing instrument operation.

Responsibilities include:
  • Hands-on testing and integration of assay workflows onto sequencing platforms.
  • Plan, conduct, analyze, interpret, and report recommendations based on tested experimental results.
  • Support product commercialization from design transfer to manufacturing.
  • Assess information to ensure data sufficiency and completeness of results.
  • Help write batch records, experimental protocols, summaries, and reports.
  • Source and qualify external vendors, develop specifications, set up supply and manufacturing process.
  • Work as part of a scientific team and participate in team meetings and initiatives.
  • Work in ISO 9001 and 13485 regulated environments.


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:
  • PhD with 3 yrs of experience or Master with 5 plus years of relevant industry experience in Biochemistry or Molecular Biology, with emphasis on product development and testing.
  • Deep understanding of biochemistry, next-generation sequencing, development of analytical and functional assays, DOE, sequencing data analysis.
  • Hand-on scientist with experience in QC assay development and validation.
  • Skilled at writing batch records, validation reports, with experience in quality management system, risk analysis and mitigation
  • Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting.
  • Knowledge of PacBio sequencing system and PLM process is a plus.


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.