Design and execute laboratory-based analytical assay development, qualification and validation. Implementation of analytical methods for the characterization, release testing and stability testing of the Company's gene and cell therapy drug products.
The Analytical Methods Development (AMD) Associate will perform laboratory-based activities to develop analytical methods for the characterization, release testing and stability testing of the Company's products of Gene Therapy, Genome Editing, and Immune Oncology Cell Therapy.
Serve as technical resource for analytical method issues. Guide the analytical characterization of products including preparation of reference standards, assay development plans, DOE and statistics for data analysis.
The Manufacturing Project Manager will co-ordinate activities related to the GMP production of early and late phase clinical materials produced at contract manufacturing organizations (CMOs) for the Company's in-house and partnered programs.
Facilitate and manage project teams and monitoring of critical path and team activities, including documenting meetings, decisions, risks and actions; cross-functional communication; and tracking of technical deliverables.
Coordinate with parties outside of finance (internal legal department, external counsel, operation leads, independent public accounting firm, members of the Disclosure Committee, and Audit Committee) to support SEC filings.
Researches, prioritizes, and follows up on incoming issues and concerns addressed to the President & CEO, including those of a sensitive or confidential nature. Determines appropriate course of action, referral, or response.
Plan and coordinate the operational and financial functions of the procurement process. Work with business unit partners and corporate leadership in the establishment, communication and implementation of business goals and work to achieve these targets.