Senior Scientist, Analytical Development

Ask Bio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

Ask Bio’s gene therapy platform includes Pro
10, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
** Our vision:
** Pioneering science to create transformative molecular medicines.
** Our mission:
** Lead innovative science and drive clinical outcomes to transform people's lives.
** Our principles:
*** Advance innovative science by pushing boundaries.
* Bring transformative therapeutics to patients in need.
* Provide an environment for employees to reach their fullest potential.
** Our values:
*** Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
* Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
* Embrace Responsibility. We are humbled by the enormity of our mission.  We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
* Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
* Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
** Position Summary
** The Senior Scientist, Analytical Development will provide the design, development, qualification and execution of analytical assays to support product and process characterization, process development, MSAT, non-clinical and GMP recombinant Adeno-associated virus (rAAV) vector manufacturing. This individual provides analytical test method development, qualification and validation support along with analytical method tech transfer for future non-GMP and GMP drug substance/product release. Responsibilities include but are not limited to, coordination of intra-team and inter-team efforts, acting as a primary point of contact, and interacting productively with stakeholders.

Other responsibilities include the assessment and implementation of new analytical technologies in collaboration with other functional groups.

The Senior Scientist, Analytical Development will report to the Associate Director, Analytical Development and be based in the RTP, NC area.
** Job Responsibilities
*** Design, establish, develop, qualify and provide validation support for biochemical assays such as ELISAs, HPLC (SEC, RP, IEX), Capillary Electrophoresis, AUC, Mass Photometry, DLS, residuals assays etc.
* Establish timelines associated with multiple analytical development projects. Provide analytical testing support for Process Development, R&D, GMP and external CMO teams to assist in the development and analytical characterization of new therapeutic targets.
* Design and coordinate/execute qualification of developed analytical methods and tech transfer the methods internally and/or to partner CMO
* Use critical analytical thinking to evaluate and draw conclusions on data from device compatibility, product comparability and product stability.
* Author development reports, study protocols, SOPs, pre-validation reports and analytical assay tech transfer documents
* Represent the analytical development team as subject matter expert in cross-site analytical meetings, CMC meetings and assist in authoring CMC-related documentation and responses…