Scientist II, Biochemistry (Reagents Process Development)

Scientist II Biochemistry (Reagents Process Development)

PacBio is seeking a highly driven and passionate Scientist II in the Reagent Development team. The candidate will be working on developing exciting products for customers and collaborating with cross-functional teams. The person will be responsible for taking products and processes from concept feasibility through to implementation into production for commercialization.

In this position the person will work closely with the R&D team(s) in demonstrating reagent feasibility and bulk formulation assay development generating product specifications developing manufacturing and QC processes and transferring these stable processes to Manufacturing. The ideal candidate will have experience with analytical technologies associated with molecular biology with an emphasis on commercial product development from concept to manufacturing. The person will characterize reagents to meet manufacturing requirements for critical reagent consumables. Candidate should have strong hands-on laboratory experience including reagent formulation sample preparation analytical assay development and preferably sequencing instrument operation.

Responsibilities include:

• Hands-on testing and integration of assay and process 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.
• Write batch records experimental protocols summaries and reports.
• Source and qualify external vendors develop specifications set up supply chain 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.

Required Qualifications:

• PhD with a minimum of 0-2 years of experience or a Masters with a minimum of 3-5 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.
• Excellent interpersonal written and verbal communication skills.
• Willingness to work and can-do attitude.

Preferred Experience:

• Knowledge of PacBio sequencing system and PLM process is a plus.

This role is not eligible for visa sponsorship.

This role is 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.

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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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