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