Department: Product Development
Reports To: VP, Technology Development
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.
Essential Duties and Responsibilities
Manage to develop new product/improve existing IVD product/group from its initiation to post marketing support based on relevant standards and regulations. Duties include the following. Other duties may be assigned.
- Be a project leader to implement design control process for development of ELISA/CLIA, multiplex assays, and other Immunoassays.
- Guide the team to generate and maintain design control documents in each design phase: design phase planning, process development, design verification, design validation, design history file, and design review record.
- Guide the risk management process
- Critical review of experiment protocol, data, and analysis, initiate proper actions
- Provide technical guides for the product development
- Design clinical study protocol and manage clinical study for regulatory submission.
- Improve assay validation and method transfer protocol by employing DOE, SPC techniques or other suitable statistical methods.
- Reduce process variation by identifying factors of process variation, thus improving process capability.
Lead team in generation of technical files for product registration with FDA (510K), Europe (CE), WHO -prequalification.
Education and/or Experience
Ph.D. of Biomedical Science with minimum 3-5 years of Industrial experience.
Experience in infectious disease, biomarker, microbiology or immunoassays is preferred.
IVD working experience with 501K, CE. Or WHO is a must
Skills and Abilities
To perform this job successfully, an individual should be proficient in Microsoft Office including Excel, PowerPoint, and Word.
Other Skills and Abilities:
- Strong literature search and analytic skills are essential.
- Statistics/SPC techniques.
- Solid background in immunology and experiment design and data analysis.
- Excellent project management skills including regulatory requirements.
- Ability to convey detailed information in English orally and in technical writing.
- MUST be able to multi-task
This position will be located at our new extended facility in Poway, California.