Senior Principal Scientist, Analytical Development
Boston, MA
Research and Technical Operations – Technical Operations /
/ On-site
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, 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.
Role Summary
Cerevel is seeking a Senior Principal Scientist with deep experience in small molecule analytical development to take on a leadership role within pharmaceutical development. The Senior Principal Scientist will report to the Head of Analytical Development as they leverage their analytical expertise across drug substance and drug product development in the pre-clinical through proof-of-concept phases.
This leader will work closely with colleagues across Pharmaceutical Development, Medicinal Chemistry, and Safety Assessment, and Regulatory CMC to drive compound selection, chemical process development, formulation development, control and stability strategies to efficiently move compounds from late discovery through preparation for phase three manufacture. The Senior Principal Scientist will recruit, train, and manage junior staff as Cerevel and our product portfolio continues to expand.
The Senior Principal Scientist will leverage our internal laboratory capabilities as well as plot the course and drive the expansion of these capabilities. To augment internal capabilities, 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 Senior Principal Scientist will grow as a subject matter expert both within and outside the department towards leading program teams and will help drive pharmaceutical development as part of this growing, dynamic team.
Key Responsibilities
- Be a recognized subject matter expert in method development and analytical characterization that enables pharmaceutical development within current and evolving worldwide regulatory frameworks
- Drive phase-appropriate pharmaceutical development
- Collaborate with formulation development, drug metabolism pharmacokinetics, and clinical pharmacology to deliver to target product profiles
- Apply innovative techniques during analytical method development, process and product characterization, control, and stability across Cerevel’s diverse portfolio of programs
- Challenge the scientific direction within the group when needed and inspire scientific rigor to bring innovative tools to aid in keeping analytical development at the front within CMC.
- Manage day-to-day 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
- Drive process and product knowledge through data analysis, report authoring, and technical presentations
- Design, support, and analyze method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects
- Author and review CMC sections of regulatory submissions and lead responses to questions and requests for additional information
- Support quality investigations or events and resolve them in a timely manner
- Identify and advocate for new and emerging technologies in analytical and physical characterization analysis
- Grow into a management role by mentoring and coaching junior staff
Required Qualifications
- Ph.D. in Chemistry, Analytical Chemistry, or related discipline with 8+ years' work experience. Similarly, a B.S. / M.S. with 15+ years' relevant work experience
- Demonstrated expertise in analytical development, method transfer, and stability program design and execution
- Experience 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 methods 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
- Strong organizational and project management skills
- Expertise in the design and execution of dissolution method development, including apparatus selection, parameter optimization, and method validation, to ensure robust and reliable data for formulation and quality control
Desired Qualifications
- Experience in crystal form characterization and control
- Experience with reference standard characterization and management of reference standard materials
- 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.
