Scientist I, Analytical Development

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Working in close collaboration with other Analytical Development team members, the Scientist I/II will develop and qualify advanced biophysical and analytical methods for AAV vectors to measure key quality attributes for AAV therapeutic materials, to support process development, product characterizations, and QC release testing.

Ultragenyx is 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 assays like, AUC(Analytical Ultra Centrifugation), MALS (multi angle light scattering), HPLCs, CE-SDS, iCIEF, LC-MS as it relates to biologics and gene therapy products. You will be responsible for the development or troubleshoot of analytical chemistry methods to further gene therapy products throughout clinical development, as well as performing BLA-enabling characterization studies to demonstrate safety, efficacy, and process consistency of our products. In this role you will be encouraged to interact and collaborate across other functions within Ultragenyx.

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Investigate and evaluate cutting edge biophysical and analytical instrumentation for AAV, AAV-Ab characterization.
• Assess and implement new assay development, such as, AUC, SEC or AF4 MALS, HPLCs, CE-SDS, iCIEF and LC-MS etc., to determine AAV capsid identity, quality, and quantity.
• Develop methods to quantitatively measure the purity and heterogeneity of AAV gene therapy vectors, including empty capsid, aggregation, and capsid protein purity.
• Provide technical support to cross-function groups and external collaborators.
• Present innovative analytical methods for characterizing and screening AAV products in both internal and external settings.
• 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.

Requirements:

• Investigate and evaluate cutting edge biophysical and analytical instrumentation for AAV, AAV-Ab characterization.
• Assess and implement new assay development, such as, AUC, SEC or AF4 MALS, HPLCs, CE-SDS, iCIEF and LC-MS etc., to determine AAV capsid identity, quality, and quantity.
• Develop methods to quantitatively measure the purity and heterogeneity of AAV gene therapy vectors, including empty capsid, aggregation, and capsid protein purity.
• Provide technical support to cross-function groups and external collaborators.
• Present innovative analytical methods for characterizing and screening AAV products in both internal and external settings.
• 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.

Physicals Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping/bending/kneeling.
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights.
• Work in a lab environment requiring special protective clothing over the face, hands, feet, and body. This role requires the ability to wear personal protective equipment. Certain tasks may necessitate the use of extra personal protective equipment if deemed necessary.
• Certain tasks may require use of a respirator; medical clearance will be required in advance. #LI-CK1 #LI-Onsite