SUMMARY/JOB PURPOSE. The Compliance QA Manager - Systems is responsible for the oversight, support, and administration of Quality Management Systems (QMS) to ensure these are effective and efficient, and maintained to support GxP functions. Supports end users and QA requirements, account management, and evaluates changes for implementation and continuous improvement initiatives. ESSENTIAL DUTIES AND RESPONSIBILITIES. As QA Core, supports QA Partn...
Summary. The Principal Investigator (PI) will be responsible for overseeing and leading clinical trials from start to finish, ensuring scientific integrity, participant safety, and adherence to all regulatory requirements. The PI will manage all aspects of clinical research, including the development of protocols, study implementation, data management, and compliance with regulatory standards. Duties and Responsibilities. The Principal Investigat...
Summary. The Principal Investigator (PI) will be responsible for overseeing and leading clinical trials from start to finish, ensuring scientific integrity, participant safety, and adherence to all regulatory requirements. The PI will manage all aspects of clinical research, including the development of protocols, study implementation, data management, and compliance with regulatory standards. Duties and Responsibilities. The Principal Investigat...
Experience. Minimum of 6 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience. Must have attention to detail and good investigation, problem solving, and organizational skills. This position requires a knowledge and experience with GxP processes related to managing vendors, partners, and suppliers. Familiarity with FDA Quality System Regulations and Pharmaceutical guid...
Job Description. We are seeking an experienced scientist in ADME/PK to join our growing research team. This role is crucial for driving the. in vitro. and. in vivo. evaluation of our therapeutic candidates, with a focus on understanding the pharmacokinetics, metabolism, bioavailability and optimal dosing regimen for novel compounds. The ideal candidate will have a deep understanding of ADME/PK principles in drug discovery and experience with DMPK...
Position Summary. We are seeking a highly motivated Temporary Scientist II to join our Preformulation and Solid-State Chemistry group within CMC Drug Product Development. The successful candidate will contribute to the characterization and development of small-molecule new chemical entities (NCEs), focusing on solid-state properties, preformulation assessments, and material sciences to support formulation design and drug product development. This...
