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Research Scientist, Analytical Development
2 months ago
*Cerevel has two positions open at this level*
As a Research Scientist in this predominately laboratory-based role, you will be responsible for supporting the analytical development and characterization of small molecule drug substances and drug products. You will work collaboratively with internal and external partners to develop, validate, and transfer analytical methods, as well as perform testing and data analysis for drug substance and drug product release and stability. You will also contribute to the preparation of regulatory submissions and quality investigations as needed. You will be part of a dynamic and innovative team that is dedicated to unraveling the mysteries of the brain and developing breakthrough therapies for neuroscience diseases.
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
