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Project Manager

Job Title:Project Manager
Department:Product Development
Reports To:Senior Management

 

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.

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.

  • 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 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.
  • 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.
  • 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.
  • Proficiency in Microsoft Office including Excel, PowerPoint and Word.
  • Expertise with DOE and statistical analysis preferred.
  • Excellent communication and technical writing skills.
  • Ability to multi-task and work on a fast-paced environment.

Please apply through Indeed.

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