Cerevel Therapeutics
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The Senior Associate Scientist will plan and execute rodent behavior experiments, analyze data, maintain compliance with animal welfare protocols, and support in vivo efforts.
Seeking a highly experienced Principal Investigator to lead drug discovery programs and provide subject matter expertise in areas of toxicology. Responsible for nonclinical safety assessment, regulatory compliance, and authoring documents for clinical trials and submissions. Must have experience in managing toxicology studies and be familiar with GLP compliance and FDA guidance.
Seeking a Principal Scientist with expertise in small molecules oral solid drug product development for late-stage clinical to commercial development. Responsible for leading drug product advancement, tech transfer, and manufacturing activities. Collaborates with cross-functional teams to drive late-stage development programs.
The Director of Labeling is responsible for managing the end-to-end label process for Cerevel products, including draft label development, label review, and labeling updates. They will also manage the internal global Core Data Sheet (CDS) process and collaborate with various stakeholders. The ideal candidate should have extensive experience in global regulatory labelling and strong technical expertise in drug label and Core Data sheet processes.
The Sr. Specialist, Quality Management (GLP) applies working knowledge in pharmaceutical research and quality assurance to provide consultation to pre-clinical development teams and performs independent quality audits of pre-clinical vendors and internal processes and systems.
Lead clinical pharmacology and pharmacometrics activities to support Cerevel’s portfolio. Responsible for planning and executing state-of-art Clinical Pharmacology program and M&S strategy. Oversee the design and protocol writing of clinical pharmacology studies. Lead or Co-lead quantitative pharmacology activities to support regulatory filings and internal decision-making. Establish tools and methods for novel solutions. Manage external contract research organizations.
Manage and maintain processes to qualify and monitor outsourced GMP activities and vendors in the pharmaceutical industry. Support GMP Vendor Management Program, audit management, quality agreements, compliance, and continuous improvement projects. Ensure vendor qualification and compliance with regulatory requirements. Provide necessary inputs for reporting key performance indicators.
Implement and maintain quality systems for GMP vendors in pharmaceutical manufacturing. Review documentation, batch records, investigations, and collaborate with stakeholders to ensure compliance with regulatory requirements. Author/update SOPs and contribute to continuous improvement activities.
Seeking a talented synthetic organic chemist for a role in Process Development as a Principal Scientist at Cerevel Therapeutics. Responsible for designing and executing multi-step organic syntheses of small molecule drug candidates, technology transfer, validation of processes, and collaborating with internal teams for drug substance manufacture.
Company Overview
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epil...
The Director of Regulatory CMC will provide expertise in translating regulatory CMC requirements into innovative, efficient, and practical strategies for development of Neuroscience candidates. They will be responsible for creating and delivering effective CMC strategies, ensuring regulatory compliance, and providing strategic input to technical teams.