The Research Associate II is primarily responsible for project-based work associated with product transfer activities from R&D to Manufacturing and Supply Chain. This position will also support sustaining and process improvement projects in Operations (this includes Manufacturing, Supply Chain, and other teams as required). Daily tasks for this role consist of writing, editing, and reviewing test methods and operating procedures, performing experiments, conducting trainings, assisting with calculator validation, and executing various studies.
To succeed as a Research Associate II in New Product Introduction (NPI) team, applicants must have strong technical writing skills and possess high proficiency with data analysis. This individual should be collaborative, organized, thorough, and willing to comply with all quality and safety standards.
* Support transfer of products and processes from R&D to Manufacturing and Supply Chain.
* Author and/or revise Standard Operating Procedures (SOPs), Forms (FRMs), Incoming Material Specifications (MSs/ISs), and other documents.
* Train Manufacturing and Supply Chain team members on new products and processes.
* Assist with calculator design in Excel and verify and validate calculators as needed.
* Perform Failure Mode and Effects Analysis (FMEA) on processes and products, analyze data and recommend improvements.
* Collaborate with impacted Manufacturing teams and, using a risk-based approach, define activities required to realize assigned sustaining projects.
* Write and review experimental plans, protocols, and technical reports.
* Design, execute, and troubleshoot experiments with manager support.
* Collaborate with other department members to conduct experiments and record findings.
* Prepare quality documentation with minimal guidance.
* Other duties as assigned.
Qualifications and Requirements:
* Bachelor's degree in a life science field.
* 2-4 years of bench experience with molecular biology techniques, preferably with at least 1 year in a GMP Manufacturing setting.
* Strong understanding of scientific concepts and biological processes.
* Excellent problem solving, verbal and written communication, resource management and computer skills.
* High level of accuracy and attention to detail, especially when multitasking.
* Ability to meet defined deadlines.
* Proficient with Microsoft Office.
* Ability to work independently and within cross-functional teams.
* Familiarity with MasterControl or other EQMS system.
* Knowledge of ISO-13485, ISO-14971 and/or QSR 21 CFR 820 is highly desirable.
* See benefits at NanoString
* NanoString is an EOE
* NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.
#IND123 AND/OR #LI-MS1
Associated topics: aseptic, bio, bioengineering, bioinformatics, biotechnology, genome, neurobiology, physical, physiology, protein