At AGTC We Are Data Geeks | Team Oriented Transparent | Quality Focused | Leaders
- Job Title
- R&D Associate
- Job ID
- Gainesville Area, FL
- Other Location
The R&D Associate on the Assay Development Preclinical R&D team is responsible for support of the Assay Development team by developing, qualifying and troubleshooting quantitative, semi-quantitative, and qualitative assays in support of research, nonclinical, and clinical programs.
- The Research Associate will report directly to the R&D Manager or designee
Duties and Responsibilities
- Develop and qualify new assay methods in support of IND enabling non-clinical and clinical studies, including in vitro cell-based assays, immunoassays, and molecular assays.
- Plan strategies for and participate in the development, qualification, and transfer of quantitative and semi-quantitative bioanalytical methods to support product release
- May assist in preparing technology transfer, assay validation and clinical sample testing at CROs
- Conduct routine assays and procedures in support of manufacturing activities for generation of viral vectors for animal studies
- May conduct testing of samples from animal studies, including but not limited to performing dose analysis testing for research studies, developing and troubleshooting routine R&D sample test methods
- Perform stability testing for critical reagents used for assays in validation phase
- Plan, execute, and troubleshoot experiments
- Collect, analyze, record, and summarize data
- Write and/or review SOPs, technical reports and study reports
- Maintain relevant laboratory supplies and equipment as needed
- Present scientific results at appropriate meetings
- Observe and comply with AGTC’s Employee manual and Safety and Quality manual
- Knowledge of laboratory safety, OSHA policies, and EPA standards
- Other duties as assigned.
- This job description is subject to change at any time
- A B.S. in biological sciences or related field
- M.S. with a degree in biological science or related field preferred
- R&D Associate I: no prior experience, one (1) year preferred
- R&D Associate II: at least two (2) years of experience
- R&D Associate III: at least five (5) years of experience, two (2) years of industrial experience in assay development is highly desirable
- Senior R&D Associate: at least eight (8) years of experience.
- The experience for all levels should be in a QC and/or AD environment focused on biologics Advanced proficiency in basic biological laboratory techniques, including ELISA, immunoblot, PCR, mammalian cell culture, and transfection
- Background in the area of retinal or genetic diseases is desired, with an understanding of AAV biology a plus
- Ability to design and develop new assay methods with minimal supervision
- Understanding/working knowledge of Microsoft Word, Excel and PowerPoint
- Ability to read and extract information from published literature and internal reports is required.
- Proficiency with SoftMaxPro, GraphPad Prism, JMP, and other common analytical software desired.
- Detail oriented with time management skills.
- Proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility.
- Knowledge of techniques such as flow cytometry and immunofluorescence are strongly desired.
- Broad knowledge of cell assay methods and biochemistry with application to gene therapy (for example, neutralizing antibody assays) is strongly desired.
- Hands-on laboratory experience in immunology, molecular biology, cell biology, virology or related areas.
- Highly motivated with the ability to work as a team player, as well as independently.
- May perform on the job training for other members of R&D
- Detail oriented with strong written and verbal communication skills
- Physical demands: (check one)
☒ sedentary (< 10 lbs.)
☐ light work (< 20 lbs.)
☐ medium work (< 50 lbs.)
☐ heavy work (< 100 lbs.)
☐ very heavy work (> 100 lbs.)
- Physical activity: (check all that apply)
- Visual acuity: reading, writing, preparing/analyzing data
- Working conditions: indoor office environment and lab area
- This position does not require previous supervisory experience