|Title:||Scientist, Analytical Development|
We are seeking a collaborative and highly technically motivated Scientist with multi-disciplinary analytical development expertise to join our Analytical Development Team. The scope includes all aspects of testing and characterization of AAV-based gene therapies including in-process testing support of upstream and downstream process unit operations and testing/extended characterization of drug substance and drug product. The position also participates in and contributes to formulation development.
- Conduct key activities include potency related analysis (cell-based assay, others as needed) of gene therapy products to support characterization, method development/optimization, methods transfer and analytical support of process development and manufacturing
- Support of development, qualification and validation of potency assays including tech transfer to CRO/CMOs
- Author/review method development reports, SOPs, validation protocols/reports, comparability protocols and technical reports
- Participate in and contribute to formulation development and supports research and development in clinical lead selection.
- PhD in a scientific discipline; and minimum of 0-2 years industry or related lab experience, or MS and 4 yrs industry experience or, equivalent combination of education + experience
- Extensive hands-on experience with development and routine assays including cell-based potency assays for biologic products. Experience with AAV testing is a strong plus.
- Experience working with various human cell lines
- Experience in CMC analytical and regulatory requirements is desirable.
- Develop, qualify/validate, and transfer fit-for-purpose QC release and stability methods
- Quality control and/or GMP experience is beneficial
- Familiar with other analytical methods used for biologics/gene therapy characterization including qPCR, ELISA and PAGE a plus.
- Must have current working knowledge of and active in the field of gene therapy or a related field;
- Demonstrated success and accomplishment in scientific creativity; sound judgment and problem-solving capabilities;
- Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence
- Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to quality control laboratory practices are highly desired;
- Previous leadership (team) experience is a plus.
- Ability to travel (10% travel time)
- Excellent problem-solving ability
- Excellent people Skills
- Excellent Organizational skills
- Exceptional interpersonal skills
- Ability to multi-task
- Possess a mind-set of no job too big or too small
- Results and detail oriented\
- Exceptional analytical skills