New Product Transfer Scientist I: Reagent Operations
MillenniumSoft Inc · San Jose, CA · 23 mo ago
AnalystFull-time
Duties And Responsibilities
- Work in new product transfer of single cell Multiomics products.
- May participate as a member of the operation team and support core team members.
- Assist in the successful transfer of products and processes into manufacturing following the Global Product Development System.
- Develop, scale up and setup the manufacturing processes.
- Prepares and submits SOP, WI, BOM, routings and standard costing for new products into SAP.
- Supports validation activities.
- Supports senior BPEs to analyze and solve problems in Production and Quality Control.
- Supports in the designing, writing and executing of protocols, reports, data analysis and other quality documents.
- May provide recommendations for process improvements.
- Trains manufacturing associates in new processes and procedures.
Requirements
- Hands on PCR, NGS, molecular biology understanding.
- Understanding of technical issues, problem solving.
- Protocol writing skills.
Qualifications
- Requires a minimum of a Bachelor’s degree in biological sciences and a minimum of 3 years of hands-on laboratory experience in a reagent process development or reagent manufacturing environment.
- Master’s degree in related field preferred.
- Working knowledge of molecular biology techniques like PCR, NGS required.
- A minimum of 1 year experience in a FDA or ISO/GMP regulated production environment.
- Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
- Experience with SAP.
Skills
- Hands on PCR, NGS, molecular biology.
- Technical issue resolution.
- Protocol writing.
Pay
N/A
Schedule
9 to 5, Mostly On-Site, Must Be Local
Benefits
N/A
Benefits
N/A
Pay
N/A
Schedule
9 to 5, Mostly On-Site, Must Be Local