The process development scientist will have strong biochemistry and molecular biology background. Candidate should have strong hands-on laboratory experience, including reagent formulations, sample preparation, analytical assay development and PacBio sequencing instrument operation. Ability to analyze data and strong knowledge of software like Excel and JMP. In this position, the candidate will contribute to the following: product transfer from R&D, manufacturing development, assay development, specification development, vendor qualification, product development, product stability studies, documentation, developing BOMs and parts for new products, manufacturing training and transfer, and QC training and transfer.
- Conduct laboratory work under general direction of supervisor.
- Hands-on testing and integration of assay workflows onto sequencing platforms.
- Help 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 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.