Research Scientist

Key Responsibilities

• Leverage Cerevel’s internal laboratories to perform analytical testing and characterization of drug substances and drug products using various techniques such as HPLC, GC, titrations, spectroscopy, and physical characterization
• Develop, optimize, and validate analytical methods for drug substance and drug product characterization and control
• Support method transfer and stability program design and execution for internal and external partners
• Review and interpret analytical data and results, and communicate findings to cross-functional teams and senior management
• Author and review analytical protocols, reports, and SOPs, and ensure compliance with cGMP and regulatory requirements
• Support quality investigations and deviations, and implement corrective and preventive actions as needed
• Identify and implement new and emerging technologies and best practices in analytical development

Required Qualifications

• Strong analytical laboratory skills and the ability to design and conduct experiments and interpret and communicate data
• Hands-on experience with analytical techniques such as HPLC, GC, titrations, spectroscopic techniques, and/or physical/solid form characterization
• Knowledge of analytical method development, validation, and transfer principles and practices
• Experience with laboratory software and systems such as ChemStation, MassHunter, and ELNs
• Strong problem-solving, troubleshooting, and analytical skills
• Excellent written and oral communication skills
• Ability to work independently and collaboratively in a fast-paced and dynamic environment

Desired Qualifications

• Knowledge of cGMP, ICH, and FDA guidelines and regulations
• Experience with managing external testing laboratories and CMOs
• Experience with solid state characterization and control (e.g., crystal form, particle size, etc.)
• Experience with QBD principles and risk assessment tools
• Experience with stability program design and execution, and familiarity with stability modeling techniques such as ASAP
• Experience with authoring and reviewing analytical sections of regulatory submissions such as INDs and IMPDs
• Passion for neuroscience and patient-centricity

Education

• Ph.D. in Chemistry, Analytical Chemistry, or related discipline with 0 - 2 years of relevant work experience