Project Manager – IVD

Department: Product Development

Reports To: Senior Manager

CTK Biotech develops, manufactures and markets diagnostic kits worldwide. Its focus is on infectious diseases and biomarkers. It intends to recruit highly motivated scientists for its product development team to manage its growing product lines.

Position Summary

The product manager will have the opportunity to oversee the lifecycle of selected CTK immunodiagnostic products, from new product ideation through commercial launch and post-market surveillance. He/She will manage the activities of multiple departments to meet timelines and achieve goals according to CTK’s priorities.

Work Environment

Equal Opportunity Employer. Reasonable accommodations are available for qualified individuals with disabilities, upon request.

Essential Duties and Responsibilities

  • Lead development of POCT immunodiagnostic product through close coordination with R&D, QA/RA, Marketing, Manufacturing and Operations departments.
  • Follow design control procedures to meet product requirements and attain IVD regulatory 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 IVD experience 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 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.

Preferred Knowledge, Skill and Experience                       

  • Strong literature search and analytic skills.
  • Leadership and ability to coordinate multidisciplinary teams.
  • Solid background in immunology and experiment design and data analysis.
  • Excellent project management skills.
  • Proficiency in Microsoft Office including Excel, PowerPoint and Word.
  • Expertise with DOE and statistical analysis preferred.
  • Familiarity with foreign languages and cultures a plus.
  • Excellent communication and technical writing skills.
  • Ability to multi-task and work on a fast-paced environment

  • Accepted file types: pdf, doc, docx.
  • This position will be located at our new extended facility in Poway (near Costco), California.

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