Associate Director/Director, Clinical Scientist

2 weeks ago

Philadelphia, United States Cabaletta Bio Full time

Associate Scientist/Scientist, Analytical Development - Tech Transfer

Philadelphia, PA

About the Position

We are seeking a talented and experienced Associated Scientist / Scientist with experience in analytical method development and validation, as well as a strong understanding of tech transfer processes of analytics to CDMO partners. Reporting to Principal Scientist of Analytical Development, the primary responsibilities of this position include planning and implementation the technology transfer, analytical oversight and assurance of consistent method performance, and investigation and resolution of deviation, for the characterization, quality control, and stability assessment of drug substance intermediates (e.g. lentiviral vector) and drug product analysis at external CDMOs.

Responsibilities Include

* Participate in evaluation and implementation of new analytical technologies and partners
* Manage the technology transfer effort of analytical methods to CDMOs. Draft and execute a method transfer plan, review method transfer qualification protocol and data to ensure seamless integration and reproducibility of methods in different laboratory settings
* Assist in reviewing and approving analytical data, reports, and documentation generated by CDMOs. Ensure accuracy, compliance, and adherence to established protocols and procedures that comply with relevant regulatory guidelines and industry best practices.
* Act as a subject matter expert to identify and troubleshoot analytical issues during tech transfer, propose and implement appropriate solutions to ensure project timelines are met.
* Perform assays for in-process and final lentiviral vector product, CART cells and CAAR T cells.
* Assist in development, optimization, and qualification of analytical methods for the analysis of drug substances intermediates and drug products.
* Assist to author method development and validation report and other technical documents for technical correctness and regulatory compliance.
* Collaborate with regulatory affairs and quality teams to ensure analytical data and documentation meet the requirements of regulatory submissions and inspections.

Required Qualifications

* A bachelor's or master's degree in relevant science discipline, with 2-5+ years' experience with tech transfer processes, including documentation, communication, and troubleshooting.
* Strong background in development, optimization, and qualification of analytical methods.
* Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously.
* Detail-oriented with strong problem-solving abilities and a proactive approach to overcoming challenges.
* Familiarity with relevant regulatory guidelines and industry best practices (e.g., ICH, FDA, EMA) for analytical method development and qualification.
* In-depth knowledge of analytical techniques, instruments, and technologies commonly used in gene-modified cell therapy products.
* Excellent communication skills, both written and verbal, with the ability to effectively collaborate with cross-functional teams and present technical information to various audiences.

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