Role Summary. We are seeking a dynamic and results-driven Associate Director of Clinical Quality Assurance (QA) to join our team. This key role will be responsible for assisting with establishing and supporting a robust QA system for our clinical operations, ensuring compliance with regulatory standards, and promoting a culture of quality throughout the organization. Key Responsibilities. Assist QA Leadership with development and execution of pla...
Role Summary. We are seeking a Director of Quality Assurance (QA) who will play a pivotal role in ensuring the quality and compliance of our operations related to vendor qualification and computer system validation. This position will be responsible for managing the assessment and qualification of GXP vendors and ensuring a validated state of GXP computer systems used at Apogee. This position requires a strategic mindset, strong leadership capabi...
Role Summary. We are seeking a Sr. CMC Project Manager to join the Technical Operations team at Apogee. This role is responsible for handling all CMC related documentation, managing the internal SharePoint site, and migration of Tech Ops documents to Veeva Quality System, as well as provide Project Management support for one or more CMC Programs. This position requires a self-starter, who can organize projects effectively in a fast-paced setting....
Role Summary. We are seeking a Medical Director to oversee the day-to-day clinical and medical execution of studies. The individual will be responsible for seamless execution of studies and support the cross-functional Development team in forming the clinical strategy with a focus on protocol development and execution. Key Responsibilities. Support development of the strategy for clinical program(s). Support design of trials and develop protocols...
Job Summary. We are seeking a knowledgeable and customer-oriented Marijuana Budtender to join our dynamic team. As a Budtender, you will be responsible for providing exceptional service to our customers, assisting them in selecting the right cannabis products, and ensuring a positive and educational experience. This is a paid position with opportunities for career growth within the cannabis industry. We believe in the development and promotion of...
Role Summary. We are seeking a Sr. Scientist, Purification Development to join the Development, Manufacturing, and Supply team. Reporting to the Purification Director, this role will be responsible for working with CDMO(s) to develop processes that enable robust production of Drug Substance (DS) and Drug Product (DP) for protein-based biologics. This interdisciplinary position will provide stewardship of cell culture and/or purification processes...
Role Summary. We are seeking an Associate Director of Biostatistics. Reporting to the Executive Director of Biometrics. In this position you will be acting as the statistical lead for one or multiple studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will partner closely with the cross-functional teams and provide expert biostatistic input on development plans, regulat...
Role Summary. We are seeking a Senior Scientist, Cell Culture Development to join the TechOps team. Reporting to the Cell Culture Director, this role will. be responsible for. working with CDMO(s) to develop processes that enable robust production of Drug Substance (DS) and Drug Product (DP) for protein-based biologics. This interdisciplinary position will provide stewardship of cell line development, cell culture and/or purification processes, i...
Role Summary. We are seeking a Trial Master File Specialist (TMF Specialist) to join the clinical operations team. In this newly created position, you will be responsible for the day-to-day management of TMF files for their respective studies, including the upload, review, and approval of TMF documents. This role will ensure that study documents are performed with adherence to ICH-GCP guidelines, other regulatory requirements, and internal and ex...
Role Summary. We are seeking a highly skilled and experienced Senior Manager of Security Operations to lead andgrow our security operations, incident response and compliance reporting. This role will collaborate within IT, with the business and with third-party vendors. In this newly created position you will be responsible for managing security vendors (including our MSP), overseeing incident response, conducting security investigations, and en...
Role Summary. We are seeking an Associate Director of FP&A. In this role, you will be an integral member of the Finance team as we build our FP&A capabilities. This position understands the business well, is highly analytical, and provides financial and strategic insights to enable the company to make well-informed decisions. This position requires the ability to effectively partner, communicate, and collaborate across the Finance team and with v...
Role Summary. . We are seeking an Associate Director, Clinical Operations – Early Development, who will be accountable for the operational management and execution of phase I clinical trials. (This role may evolve over time to include Phase 2-3.) This role will primarily oversee the centralization and management of our Ethnic Bridging trials across multiple compounds. Ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as wel...
