Essential Duties and Responsibilities Lead development of POCT immunodiagnostic or PCR product through close coordination with R&D, QA/RA, Marketing, Manufacturing and Operations departments. Follow design control procedures to meet product requirements and attain IVDregulatory approval. Conduct product evaluation studies through national and international collaborations or reference laboratories. Collaborate with RA to generate technical files to support product registration. Provide technical support to sales staff and global customers. Supervise experimental design, clinical studies, and data analysis using IVDexperience and scientific knowledge. Duties and responsibilities may be changed as per company priorities.
Education and/or Experience Advanced degree in Biomedical Sciences, PhD is preferred. Minimum of 2-3 years of experience with IVD development is required, expertise with Lateral flow tests or PCR is a plus. Background in infectious diseases, microbiology or immunoassays. Expertise in design control and risk management guidelines for In Vitro Diagnostics. Project management experience, in industry setting preferred.
Skills and Abilities: Strong literature search and analytic skills. Leadership and ability to coordinate multidisciplinary teams. Solid background in immunology or PCR and experiment design and data analysis. Excellent project management skills.
Poway 生物公司内推Product/Project manager
Essential Duties and Responsibilities
Lead development of POCT immunodiagnostic or PCR product through close
coordination with R&D, QA/RA, Marketing, Manufacturing and Operations
departments.
Follow design control procedures to meet product requirements and attain IVDregulatory approval.
Conduct product evaluation studies through national and international
collaborations or reference laboratories.
Collaborate with RA to generate technical files to support product
registration.
Provide technical support to sales staff and global customers.
Supervise experimental design, clinical studies, and data analysis using IVDexperience and scientific knowledge.
Duties and responsibilities may be changed as per company priorities.
Education and/or Experience
Advanced degree in Biomedical Sciences, PhD is preferred.
Minimum of 2-3 years of experience with IVD development is required,
expertise with Lateral flow tests or PCR is a plus.
Background in infectious diseases, microbiology or immunoassays.
Expertise in design control and risk management guidelines for In Vitro
Diagnostics.
Project management experience, in industry setting preferred.
Skills and Abilities:
Strong literature search and analytic skills.
Leadership and ability to coordinate multidisciplinary teams.
Solid background in immunology or PCR and experiment design and data
analysis.
Excellent project management skills.
公司提供有竞争力的福利待遇包括PTO,401K match和医疗保险等。
我可以帮你内推. 公司地点Poway
请发简历至[email protected] 谢谢。