Analytical Development Scientist
4 weeks ago
Gene Therapy is a division focused on developing novel treatments for rare diseases. Our team is comprised of biotech veterans and industry leaders in gene therapy and rare diseases. We are focused on advancing our platform of gene therapy programs through clinical development, starting with lead programs in hemophilia and metabolic disorders of the liver, and building out a world-class product engine for adeno-associated virus (AAV) therapeutics. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and will contribute to advancing the field of AAV gene therapy.
Position Summary
Seeking an analytical chemistry scientist with a collaborative and
innovative mindset to join our Analytical Development group in Woburn, MA. Strong preference will be given to a candidate with proven experience in developing biophysical and analytical chemistry assays like SEC-MALS, HPLCs, CE-SDS, iCIEF as it relates to biologics and gene therapy products. 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
Responsibilities
• 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 partners. 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
• PhD in Analytical Chemistry, Biophysics, or related fields with 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.
• Hand-on experienced with SEC-MALS, HPLC, CE, DLS, and more
instruments are desired.
• Knowledge of analytic methods for quantification and characterization of
AAV vectors and Protein is desired.
• Strong, demonstrated ability to work independently, maintain a high level
of productivity, focus on priorities, and thrive in a fast-paced biopharmaceutical
environment.
• Ideal candidate must be team focused and demonstrate high level of
integrity.
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