A leader in the pharmaceutical industry is seeking a Scientist to join their team. Reporting to the Associate Director of Analytical Development, the Scientist will be responsible for the development of biophysical and analytical chemistry methods to further gene therapy products throughout clinical development, as well as performing BLA-enabling characterization studies. In this role you are encouraged to interact and collaborate across other functions within the company.
**H1B transfers not permitted** **Full time onsite - half in lab half in office**
Responsibilities: The Scientist will:
Investigate and evaluate cutting edge biophysical and analytical instrumentation for AAV, AAV-Ab characterization
Develop methods to quantitatively measure the purity and heterogeneity of AAV gene therapy vectors, including empty capsid, aggregation, and capsid protein purity
Evaluate and implement new analytical platforms, such as Mass Photometry, SEC-MALS, and HPLC, to characterize AAV particles
Provide technical support to cross-function groups and external collaborators
Effectively collaborate with internal analytical development teams and manage the transfer of analytical methods to business partner
Provide guidance and foster effective communications during the tech transfer
Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs) for internal use and transfer to external sites
Qualifications:
Experience in Analytical Development for biologics or gene therapy products
Demonstrated ability to bring efficiency and innovations into analytical testing and operation
Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with business partners
Strong, demonstrated ability to work independently, maintain a high level of productivity, focus on priorities, and thrive in a fast-paced biopharmaceutical environment
Master's Degree with adequate experience
Solid analytical and research skills
Desired Skills:
PhD in Analytical Chemistry, Biophysics, or related field
Hand-on experienced with SEC-MALS, HPLC, CE, DLS, and more instruments
Knowledge of analytic methods for quantification and characterization of AAV vectors and Protein