Senior Scientist, Analytical Development

Asklepios BioPharmaceutical, Inc. (AskBio) • Durham, NC

73d

About The Position

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.

Requirements

• MS with 10+ years' experience OR PhD with 5+ years' experience in Bioanalytical Chemistry, Biochemistry, Molecular Biology, Biology, Virology or related field.
• Excellent interpersonal skills with the ability to interact effectively with people, internally and externally.
• Self-motivated, organized, capable of working independently as well as in a collaborative/group environment.
• Capable of managing a group of analysts/scientists.
• Expertise with method development, qualification and validation following regulatory guidelines (USP, ICH etc).
• Excellent oral and written communication skills.
• Good judgment and innovation to achieve a solution within standard practices and procedures.
• Proven ability to work independently in a fast-paced environment, meet deadlines, and prioritize work on multiple projects.
• Strong attention to detail.

Nice To Haves

• Prior industry experience in gene therapy.

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 to health authorities when needed (FDA, EMA, MHRA etc) queries.
• Evaluate CRO/CMO test results and writing summary reports of the results when needed.
• Establish CRO relationships when needed.
• Contribute to technical discussions and investigations within the analytical group and help support process development, MSAT, QC, non-clinical and GMP manufacturing.
• Act independently to define new assignments that generate innovative methods and procedures.
• Bring in new technologies for characterization of AAV drug products.
• Exhibit expert skills in synthesizing research findings and effectively communicating findings and recommendations to senior management independently.
• Perform detailed, organized, formal record keeping.
• Manage a group (up to 4 people) of scientists and research associates performing laboratory activities.

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees