AskBio Inc. · 11 hours ago
Senior Scientist, Analytical Development
Durham, NC
Full-time
Onsite
Senior Level
5+ years expAskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The Senior Scientist, Analytical Development will design, develop, and qualify analytical assays to support product and process characterization, and will coordinate efforts across teams while interacting with stakeholders.
BiopharmaBiotechnologyHealth CareManufacturingMedicalMedical Device
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. Must be able to generate high quality data for presentations and publications
Manage a group (up to 4 people) of scientists and research associates performing laboratory activities
Qualification
Required
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
Preferred
Prior industry experience in gene therapy
Company
AskBio Inc.
AskBio 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.
501-1000 employees
H1B Sponsorship
AskBio Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (4)
2022 (8)
2021 (3)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$241.76MKey Investors
Scottish Enterprise
2020-10-26Acquired
2020-09-02Grant· $2.66M
2019-04-11Private Equity· $235M
Leadership Team
S
Samuel Hopkins
Sr. Vice President, Therapeutics
Mansuo L Shannon
Board Member
Recent News
Asklepios BioPharmaceutical, Inc. (AskBio)
2025-10-21
Company data provided by crunchbase