Scientist, Process Development
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.
- Masters or Ph.D. in Molecular Biology, Biochemistry, or related scientific discipline preferred.
- 1-2 years of relevant industry experience in life sciences, medical devices, diagnostics, biotechnology, pharmaceutical or related scientific fields preferred.
- Experience in a development / manufacturing environment preferred.
- Has expertise in biochemistry, chemistry, and molecular biology.
- Must be hands-on in the laboratory and ability to troubleshooting
- Effective verbal and written communication skills especially experience with writing SOPs and Batch records.
- Strong collaboration and teamwork.
- Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting.
- Knowledge of 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.