This role will focus on Immunodiagnostic assay development using the product development process, including raw material screening, feasibility, optimization, verification, validation, and manufacture transferring to product launch. The incumbent must have the technical insights to troubleshoot complex problems, work with multifunctional teams, analyze data sets, write protocols/SOPs, and generate technical reports. Activities in this role include presenting technical aspects of assignments, leading team efforts, working effectively with all levels within the department, and being responsive to project priorities.
- Leads projects for immunodiagnostic assay development in various disease areas
- Mentors junior level Research Scientist/Associates/Assistants
- Leads the evaluation and qualification of materials following established protocols and procedures
- Leads/Executes the product development plan to demonstrate assay feasibility & generate technical reports
- Identifies project needs and assists in sourcing critical raw materials, clinical samples, and other supplies
- Be responsible for product optimization, technical support for manufacturing scale-up, SOP generation, and product quality control establishment
- Delivers quality work, follows established SOPs and GLP guidelines, maintains good documentation records by complying with Good Documentation Practices (GDP)
- Participates in activities across multifunctional teams to assist in product launch
- Working closely with other researchers in a team environment
- Perform other assignments as designated by upper management.
- Ad hoc projects/tasks assigned by the management.
QUALIFICATIONS AND EXPERIENCE
- Bachelor, Master, or Ph.D. in biochemistry, biology, life science, chemistry, or a related field
- Ph.D. degree with a minimum of 1-year hands-on experience working in immunoassay development or Master's degree with a minimum of 3 years’ experience or Bachelor's degree with a minimum of 8 years experience
- Excellent written and verbal communication skills, reasoning ability, and critical thinking
- Experience in managing junior researchers
- Ability to work effectively in a multi-disciplinary environment
- Demonstrated track record of product optimization, manufacturing scale-up, assay quality control establishment
- Knowledge of GLP and GDP guidelines
- Ability to contribute in a diverse team environment
- Hands-on experience in the development of qualitative, semi-quantitative, or quantitative immunoassays or other complex immunoassay systems
- Previous experience with antibody selection and conjugation, protein purification, characterization, and labeling is a plus
- Planning and execution of verification and validation plans, and generation of technical reports
- Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc)
At AdvanBio, we work in an environment where diversity is essential, inclusion is our culture, and each person knows they belong and matter.
We offer a comprehensive benefits package including paid holidays and vacation, affordable medical, dental, life insurance, and retirement plans. You will be eligible for benefits on your first day of employment.
We are an Equal Opportunity Employer (U.S.). You will receive consideration for employment without regard to race, color, religion, national origin, age, citizenship, gender, marital status, pregnancy, sexual orientation, gender identity and expression, disability, or veteran status.