Principal Scientist, Process Development
Boston, MA
Research and Technical Operations – Technical Development /
Full Time /
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 Therapeutics is seeking a talented synthetic organic chemist for a role in Process Development as a Principal Scientist. The Principal Scientist will apply and grow their expertise in small molecule drug substance synthetic process development as they contribute to Cerevel’s pursuit of its rich small molecule pipeline spanning pre-clinical through commercial candidates. This is a tremendous opportunity to apply and grow your skills in process development activities from the discovery chemistry interface (form selection and toxicology batch production) to preparation for commercial launch activities. Aided by and leveraging Cerevel’s internal laboratory capabilities while managing external partners, the Principal Scientist will develop scalable, cost-efficient, environmentally-sound synthetic processes for Cerevel’s novel candidates. This is an opportunity to be a part of a well-funded, growing, and collaborative company with a shared goal of realizing Cerevel’s mission of delivering innovative therapies for CNS disorders like Parkinson’s, Alzheimer’s, and epilepsy.
Key Responsibilities
- Drive design and execution, both internally and through external partners, of multi-step organic syntheses of small molecule drug candidates as a member of cross-functional development teams
- Provide input and guidance to the planning, execution, and oversight of the technology transfer and validation of processes with CMO partners, ensuring the quality, safety, and efficacy of the product throughout the process
- Independently apply sound scientific principles and creative thinking to ensure the selection of innovative and robust synthetic routes, pharmaceutical forms, and compound properties for development and scale-up of drug substance manufacture
- Leverage literature review and ongoing awareness of state of the art in designing and executing new routes
- Collaborate with Cerevel’s Global Quality Assurance function on investigations or events and resolve them in a timely manner
- Contribute to the completion of reports necessary to support regulatory strategies and filings such as INDs, NDAs, IMPDs, and NDAs
- Present technical data to cross functional teams and senior management
- Collaborate with internal groups such as Analytical Development, Formulation Development, Supply Chain, Global Quality Assurance, and Regulatory CMC to advance Cerevel’s pre-clinical and clinical candidates
Required Qualifications
- Significant experience in small molecule process development from early phase route scouting through process optimization and scale-up toward late-phase clinical development
- Hands on crystallization experience and working knowledge on solid polymorphic screening
- Exposure to technology transfer and process development and working with external partners to achieve process development goals and manufacturing
- Familiarity with the preparation of process, analytical, and characterization reports suitable to support regulatory filings
- Management of on-time API deliveries for toxicology studies, formulation development, and preclinical and clinical studies
- Familiarity with potential genotoxic impurity assessments
- Working knowledge of the core analytical techniques such as HPLC, GC, LCMS, and NMR
- Sound understanding cGMPs, ICH guidelines, applicable regulatory guidance
- May require up to 10% travel
Desired Qualifications
- Hands-on experience with 50+ kg deliveries and registration batches
- Experience in process chemistry development at a sponsor company for compounds in phase 1 and 2
- Desire to work in a fast-paced, dynamic environment
- Desire and willingness to contribute to lab-based activities
- Strong, independent problem solving and trouble shooting skills
- Demonstrated capability to collaborate with analytical chemists, formulators, toxicologist, and quality professionals
Education
- PhD in Organic Chemistry with a minimum of 5 years’ relevant work experience
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.
