Department: Product Development
Reports To: Senior Manager
Duties and responsibilities may be added, deleted, or changed at any time at the discretion of management, formally or informally, in either verbal or written form. Reasonable accommodations are available for qualified individuals with disabilities, upon request.
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.
Essential Duties and Responsibilities
Manage product development from its initiation, development, and post marketing support based on relevant standards and regulations. Duties include the following.
- Analyze product demand, competition and post market feedback to propose product development and improvement, to introduce new technologies.
- Be the key person to manage and coordinate the product development and improvement process through close communication with R&D team, QA/RA team, marketing team, purchasing team.
- Work closely with counterpart in China, including travel as required.
- Review experiment design, data, and analysis.
- Acquire specimens and reference tests, conduct product evaluation studies through national and international collaboration or reference lab.
- Generate 510K or CE technical files to support product registration in USA and Europe.
- Provide technical support to sales staff and global customers. Help in handling product complaints.
- Other duties may be assigned.
Education and/or Experience
Master or Ph.D. of Biomedical Science is required. Experience in infectious disease, biomarker, microbiology or immunoassays is preferred. IVD experience is a plus, but not required. Experience in industry settings preferred. Prior project management experience is a must.
Candidates with 2-3 years of laboratory research experience who want to move to the industry for future growth will be considered.
Skills and Abilities
- To perform the job successfully, an individual should be proficient in Microsoft Office including Excel Spreadsheets, PowerPoint, and Word.
Other Skills and Abilities:
- Strong literature search and analytic skills are essential.
- Strong leadership.
- Solid background in immunology and experiment design and data analysis.
- Excellent project management skills.
- Familiarity with foreign languages and cultures a plus.
- Fluency in Chinese a plus.
- Excellent technical writing skill.
- Ability to multi-task.
This postion will be located at our new extended facility in Poway, California.