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.
CTK Biotech develops, manufactures, and markets immunodiagnostic kits worldwide. Its focus is on infectious diseases and biomarkers. It intends to recruit highly motivated scientists for its product management team to manage its growing product lines.
Support CTK Product Development by performing the following duties:
Essential Duties and Responsibilities
Manage product life cycle from its initiation, development, and postmarketing support based on relevant standards and regulations. Duties include the following. Other duties may be assigned.
- Analyze product demand, competition and postmarket feedback to propose product development and improvement, to introduce new technologies.
- Be the key person to manage the entire product development and improvement process through close communication with R&D team, QA/RA team, marketing team, purchasing team.
- Review experiment design, data, and analysis.
- Acquire specimens and reference tests, conduct product evaluation studies through international collaboration.
- 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.
- Analyze global IVD market. Help senior management develop strategies for all products to allow CTK to stay ahead of global competition.
- Involvement in new target discovery and IP development.
- Support development of product marketing material.
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, but not required.
Ideally candidates are these who want to move to industry after few years of laboratory work.
Skills and Abilities
- To perform this job successfully, an individual should be proficient in Microsoft Office including Excel Spreadsheets, Power Point, and Word. Adobe Photoshop and Illustrator is a plus.
Other Skills and Abilities:
- Strong literature search and analytic skills are essential.
- Solid background in immunology and experiment design and data analysis.
- Excellent project management skills.
- Familiarity with foreign languages and cultures a plus.
- Ability to convey detailed information in English orally and in writing.
- Excellent technical writing skill.
- Ability to multi-task
- Moving to new facility at Poway soon.