Analytical Development Scientist

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Woburn, United States Planet Pharma Full time

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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