Key Responsibilities amp; Accountabilities:
- Work collaboratively with Research to assist with transfer of assays into AD.
- Perform assay development and optimization.
- Collaborate with PD to generate data to support formulation studies, stability studies, and characterization of drug substance and/or drug product.
- Document all experimental work, supporting information, and data in an electronic lab notebook (eLN) in a timely manner.
- Compile and present data and assist in authoring and reviewing of test methods, technical reports, and supporting procedures.
- Assist in the technical transfer of assays to Quality Control or central testing laboratories.
- Support testing of reference standards, lead stability samples, forced stability samples, toxicology lots, non-human use (NHU) engineering runs, and clinical manufacturing runs, as appropriate.
- Cross-train personnel on assays, as required, and provide guidance to junior research associates.
- Other responsibilities as required.
Requirements
Knowledge, Skills amp; Capabilities:
- Experience with applicable protein, RNP, and/or AAV analytical methods. This includes biophysical experience in methods such as HPLC/UHPLC assays, CE-SDS, SDS PAGE experience with molecular techniques such as ddPCR/qPCR, ELISA, and cell-based assays will also be helpful.
- Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.
- Strong verbal and written communication skills.
- Knowledge of CRISPR/Cas9 gene editing technologies.
- Development and/or technical transfer of GMP test methods for biologics.
Education amp; Relevant Work Experience:
- Bachelor’s experience in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 5+ years of relevant experience or Master’s with 2 years of experience.