Write and edit documents required to develop products for IVD, LDT, CE Mark, and RUO product offerings
Develop and manage timelines for document development and completion
Interface with cross functional teams including business development, computational biology, software, quality assurance, operations and validation teams to seek input for product development
Understand NGS immunosequencing PCR assays, sequencing data and statistical analyses other duties may be assigned Developing assays under design control
Multiplex PCR, and NGS technology preferred
Proficiency in verbal and written English
Demonstrated capacity for problem solving and identifying solutions
Must work independently and be able to prioritize and manage multiple projects
Proficiency in Microsoft Office, Microsoft Excel, Microsoft Project is required.
Knowledge of database tools such as Tableau, Visio or similar tools is desired.
All other duties as assigned

Requirements

Education: B.A./B.S. in biology or chemistry or related field (molecular biology, immunology, etc.) required. Advanced degree preferred (MS or Ph.D.)
Years of industry experience: B.S., 10+ years, M.S. 8+ years, or Ph.D. 5+ years.
At least 3 years of wet-lab experience required
Experience in the biotechnology or pharmaceutical industries and working in regulated environment is required.
Experience with ISO 13485, ISO 14971, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements is required.

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

IVDLDTCE MarkRUONGS immunosequencing PCR assaysMultiplex PCRstatistical analysesdocument developmentdesign controlwet-lab experience

Soft Skills

problem solvingindependent workprioritizationproject managementcommunication

Certifications

ISO 13485ISO 14971CLIACAPCLEPGxP