Principal Scientist, Analytical Development
Research and Technical Operations – Technical Operations /
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, epilepsy, Parkinson’s disease and substance use disorder.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Cerevel is seeking a Principal Scientist with significant experience in analytical characterization and control with an emphasis on pre-clinical to phase 2 programs to join our Analytical Development group in Cambridge, MA. The Principal Scientist will report to the Director of Analytical Development, and they will provide analytical expertise in drug substance and drug product analytical development for small molecules from pre-clinical through phase 2 development and manufacturing. They will work closely with colleagues across pharmaceutical development, medicinal chemistry, and safety assessment to best leverage Cerevel’s internal development capabilities including process chemistry, analytical, and formulation development labs, instruments, and equipment. Additionally, they will identify and manage external partners for method development as well as analytical testing and characterization across Cerevel’s portfolio of pre-clinical and clinical-stage programs. The Principal Scientist will grow as a subject matter expert both within and outside the department and will help drive pharmaceutical development as part of this growing, dynamic team.
- Provide subject matter expertise in analytical development activities at Cerevel requiring internal laboratory execution
- Guide and drive analytical method development, implementation as well as drug substance and drug product characterization and control for Cerevel’s pre-clinical and clinical stage development programs
- Provide technical support and day-to-day management of outsourced drug substance and drug product method development activities with CMO partners
- Manage analytical testing activities including in process, drug substance and drug product release and stability testing through review of analytical data
- Present technical data to cross functional teams and senior management as an expert in analytical development for Cerevel’s pre-clinical and clinical-stage development programs
- Design, support, and analyze method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects
- Author and review drug product and drug substance analytical sections for regulatory submissions
- Support any quality investigations or events and resolve them in a timely manner
- Train and recruit Analytical Development lab staff as needed
- Identify and advocate new and emerging technologies in analytical and physical characterization analysis
- Partner with Chemical Process Development and Formulation Development staff to assess and support drug substance and drug product characterization and retest/shelf-life setting
- Ph.D. in Chemistry, Analytical Chemistry, or related discipline with 5+ years' work experience. Similarly, a B.S. / M.S. with 10+ years' relevant work experience
- Demonstrated expertise in analytical development, method transfer, and stability program design and execution
- Experience with managing external testing laboratories during clinical-stage pharmaceutical development
- Subject matter proficiency in the analytical development of oral formulations with experience in discriminating dissolution test method development, HPLC, GC, titrations, spectroscopic methods, and physical characterization techniques such as X-ray powder diffraction, DSC, and TGA
- Familiarity with laboratory software and systems including, but not limited to: Open lab CDS software suite, MassHunter, and Dotmatics for Electronic Lab Notebooks (ELN)Knowledge and the ability to interpret and draw conclusions from data from analytical techniques employed across drug substance and drug product development
- Ability to troubleshoot analytical method and testing issues, determine causes and possible solutions
- Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment
- Experience with the fundamentals of dissolution method development, including apparatus selection, parameter optimization, and initial steps of method validation, contributing to formulation and quality control
- Experience in crystal form characterization and control
- Exposure to QBD principles and stability modeling techniques such as ASAP
- Experience in authoring and reviewing analytical components of drug substance and drug product sections of INDs as well as IMPDs
- A Team player capable of pushing for individual and team growth
- Experience managing trend analysis and supporting analytical method life-cycle management and continuous improvement
- Desire to work in a fast-pace, dynamic environment with capability of being a CMC lead on programs
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.