American Gene Technologies is a leader in cell and gene therapy of infectious diseases, monogenic diseases, and cancer. Located in Rockville, Maryland, we are expanding the capacity for Research and Development of novel therapies and are seeking a Senior Associate Scientist for our Translational Science group.
This group facilitates pre-clinical development of cell and gene therapy products, manages IND-enabling studies and standardizes procedures and protocols coming from our Discovery group. The successful candidate must be skilled and experienced in the practice of bioanalytical assay development and qualification in an industrial setting.
- Develop and qualify bioanalytical assays relevant to our programs in infectious disease, monogenic disease, and cancer
- Support technology transfer of assay procedures to vendors and partners
- Write and review internally and externally developed analytical procedures and study protocols and reports
- Work with Quality Assurance to ensure laboratory practices are in line with our current Quality procedures
- Identify process improvement opportunities and alternate approaches for supporting product development and clinical testing
- Provide technical insight and administrative oversight for animal studies performed through vendors and partners to achieve both early stage discovery research milestones and preclinical product development
- Perform additional tasks or assist with special projects, as assigned
Skill, Knowledge and Abilities Required:
- Masters or Bachelor’s degree in biochemistry, immunology, virology, or a related field
- At least 7 years’ experience with a Bachelor’s degree or 5 years’ experience with a Master’s degree in an industrial laboratory environment
- Gene and cell therapy experience is preferred
- Experience with Good Documentation Practices (GDP)
- Experience with assay development, execution, and troubleshooting
- Strong skill set pertaining to mammalian cell tissue culture, virology and immunology assays including flow cytometry, peptide or polyclonal stimulation of T cells, cytotoxicity assays, ELISA, and viral titer assays.
- Molecular biology skills are a plus, particularly cloning, techniques to evaluate gene expression such as qPCR and in situ hybridization and evaluating protein expression and function such as western blot and enzymatic assays
- Experience maintaining flow cytometers is a plus
- Experience converting manual processes to an automated process or implementing high throughput tricks of the trade
- Excellent computational skills for data analysis
- Excellent communication and interpersonal skills
- Demonstrated ability to take initiative and be a pro-active team member
Working Conditions and/or Physical Requirements:
This is a laboratory role that requires physical mobility and physical effort. Biohazard precautions are required for working with gene therapy vectors, animal or human blood and tissue, or human pathogens.
The position reports directly to the Translational Sciences Laboratory Manager, then the Director of Preclinical Product Development and finally to the Chief Science Officer.
American Gene Technologies (AGT) is an equal opportunity employer and will consider applications without discriminating on the basis of disability, sex or sexual orientation, race or ethnic origin, marital or civil partnership status, or any other characteristic protected by law. AGT employees receive competitive salaries, comprehensive healthcare coverage, paid gym membership, 401K plan with employer contribution, incentive stock options and annual paid leave.