Cerevel Therapeutics
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Senior Specialist, Platform Oversight responsible for and supports clinical technology solutions at a program level. Liaises between internal and external technology providers and Clinical staff to ensure understanding. Manages testing configuration changes and supports clinical study teams in UAT scripts for technology implementations. Represents Clinical Oversight on cross-functional teams. Minimum 5 years industry experience with 2 years in GxP-validated clinical technology solutions.
Looking for an experienced Drug Safety/pharmacovigilance professional to oversee safety vendor management and ensure compliance with regulations. Key responsibilities include managing safety case workflow, resolving queries, and presenting safety reporting processes. Requires up-to-date knowledge of global regulations and industry guidelines.
The Senior QA Specialist, Global Product Quality ensures GMP compliance for outsourced manufacturing, packaging, labeling, testing & distribution activities. They review GMP documentation, batch records, analytical data, and quality investigations. Collaborates with vendors and internal teams to identify and mitigate quality risks. Supports continuous improvement activities and document updates.
Cerevel Therapeutics is seeking a Principal Engineer, Process Development for their Late-phase and Commercial group. The role involves extensive knowledge and experience in small molecule process development, with a focus on late-phase clinical to commercial chemical process development. The Principal Engineer will be responsible for guiding and providing direction to external partners, leading the optimization of synthetic routes and unit operations, and providing technical support for outsourced drug substance development activities. The successful candidate will have strong communication and cross-functional collaboration skills.
The Senior Scientist will have significant experience in analytical method development, analytical characterization, and control with an emphasis on late clinical-stage to commercial development. They will work closely with colleagues across pharmaceutical development to best leverage Cerevel's internal development capabilities including process chemistry, analytical, and formulation development labs, instruments, and equipment.
The Director of Analytical Development will lead and develop a group of scientists while tackling challenging analytical method development and data interpretation problems. They will drive stability strategy and provide input on regulatory strategies.
Manage controlled documents and support regulatory submissions in the biotechnology or pharmaceutical industry. Ensure accuracy, completeness, and compliance with document control standards. Collaborate with cross-functional teams to track deliverables and improve processes.
Seeking a Senior Scientist for Process Development at Cerevel Therapeutics to contribute to the development of small molecule drug substances for CNS disorders. Responsibilities include lab work, process optimization, and scientific discussions to support the company's pipeline. Desired qualifications include experience in chemical engineering principles, synthetic process development, and laboratory work.
Seeking a talented synthetic organic chemist for a role in Process Development as a Principal Scientist at Cerevel Therapeutics. Responsible for driving design and execution of multi-step organic syntheses, technology transfer with CMO partners, selection of innovative synthetic routes, and contributing to regulatory filings.