Sr Scientist, Quality Control and AD

Description

Job Title:

QCAD Scientist I, Scientist II, Sr Scientist

Location:

Houston Headquarters Facility

Department:
Quality

Reports To:

QCAD Manager

FLSA Status:
Full Time/Exempt

Sr Scientist, Quality Control and Analytical Development (QCAD) is responsible for providing scientific and technical leadership in support of analytical development and GMP Quality Control activities for gene therapy products. The incumbent will lead and execute analytical method development, optimization, qualification/validation, method transfer, troubleshooting, and implementation of methods for routine GMP testing. The focus area of this role is primarily on HPLC methods but will be involved with other analytical methods.

The Sr Scientist will serve as a technical resource within QCAD, applying scientific expertise to the development and lifecycle management of analytical methods supporting raw materials, in-process samples, drug substance, drug product, stability, characterization, and product release testing. The role will lead new project implementation and execution in a timeline-driven manner, support client and cross-functional technical interactions, and mentor junior scientists and laboratory staff.

The final job title, level, and scope of responsibilities may be adjusted to Scientist I, Scientist II, or Senior Scientist based on the selected candidate’s education, relevant experience, technical expertise, and demonstrated capabilities.

• Lead and participate in laboratory capability development activities, including implementation of new analytical technologies, equipment acquisition and qualification, method implementation, laboratory readiness, and coordination with vendors and internal stakeholders. Maintain a high level of scientific and technical expertise in analytical technologies applicable to viral vectors, biologics, and gene therapy products.
• Design, develop, optimize, and troubleshoot analytical methods supporting product characterization, process development, in-process control, release, and stability testing.
• Lead analytical method qualification/validation, verification, transfer, comparability, and implementation activities, including development of study strategies, protocols, acceptance criteria, data analysis, and technical reports.
• Serve as a technical owner and subject matter expert for assigned analytical methods and platforms, providing scientific oversight throughout the analytical method lifecycle.
• Provide technical leadership across analytical technologies that may include qPCR/ddPCR, ELISA, electrophoresis, HPLC/chromatographic methods, cell-based assays, potency assays, and other molecular, biochemical, biophysical, or microbiological methods.
• Perform and provide technical oversight for routine and non-routine GMP testing of raw materials, in-process samples, drug substance, drug product, stability samples, characterization samples, and other materials, as applicable.
• Participate in technical discussions with clients and serve as a QCAD subject matter expert for assigned analytical methods, assay strategies, investigations, and analytical development activities.
• Lead and support analytical method transfers from Analytical Development, Process Development, clients, external laboratories, or other sites into the GMP QCAD laboratory, ensuring methods are appropriately implemented and analysts are successfully trained and qualified.
• Independently design and execute analytical development, characterization, method optimization, comparability, routine QC testing, and troubleshooting studies using scientifically sound experimental approaches.
• Establish appropriate experimental designs, controls, system suitability criteria, and acceptance criteria based…