Principal Scientist, Process Development (Engineer)
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 has two (2) positions open at this level.
Cerevel is seeking a Principal Engineer, Process Development for a role in our Late-phase and Commercial (LP&C) group. The individual should have extensive knowledge and experience in small molecule process development with an emphasis on late-phase clinical to commercial chemical process development to join our CMC Technical Operations group in Cambridge, MA. The Principal Engineer will report to the engineering lead and drive drug substance process development supporting post-proof of concept chemical process characterization, factory implementation, process performance qualification, and long-term commercial supply.
The Principal Engineer will guide and provide direction to external partners for late-phase development through long-term commercial manufacturing while making contributions to Cerevel’s late-stage programs. The Principal Engineer should have a strong, proven track record in communicating Technical Operations input and considerations in cross-functional settings as well as with external partners. Aided by and leveraging Cerevel’s internal laboratory capabilities and capabilities of external partners, the Principal Engineer will ensure development of 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, schizophrenia, and epilepsy.
- Drive the design and execution of development and scale-up activities both internally and externally for Cerevel’s late-phase to commercial programs
- Promote collaboration with cross-functional technical operations, quality, and regulatory CMC partners to deliver on the integrated program CMC strategy
- Lead the optimization of synthetic routes and unit operations appropriately to support commercial scale-up by applying sound scientific and engineering principles
- Provide technical support of outsourced drug substance development activities with CMO partners
- Guide manufacturing activities including oversight of production campaigns (some travel necessary), reviewing batch records, and processing analytical batch data
- As a technical leader for Cerevel’s late-stage development programs, present technical data to cross-functional teams and senior management when needed
- Lead 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
- Collaborate with analytical CMC colleagues to assess and ensure the development of robust drug substance raw material, in-process, and final release and stability methods
- Drive to the completion and/or review of reports necessary to support regulatory strategies and filings such as INDs, NDAs, IMPDs, and NDA
- Author and review of CMC sections for regulatory submissions
- Collaborate with Global Product Quality to investigate quality events and resolve them in a timely manner
- Identify and advocate new and emerging technologies in synthetic process development and commercial manufacturing
- 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 synthetic routes
- Demonstrated experience in leading and guiding late-phase and commercial process development, tech transfer, scale-up, optimization, and validation
- A minimum of 5 years’ relevant work experience post-Ph.D
- Demonstrated application of QbD principles and the design, implementation, and analysis of DOEs
- Experience in authoring and reviewing drug substance sections of late-phase INDs and NDAs
- Proven knowledge of cGMPs in pharmaceutical development and manufacturing environments, ICH guidelines, and applicable regulatory guidance
- Experience collaborating with CDMOs during late clinical-stage pharmaceutical development and product commercialization
- A team player, capable of leading and pushing for individual and team growth in a fast-paced, dynamic environment
- Hands-on experience with 50+ kg deliveries and registration batches
- Experience with the preparation of process, analytical, and characterization reports suitable to support regulatory filings
- Experience performing ICH M7 and potential genotoxic impurity assessments
- Desire and willingness to contribute to lab-based activities
- May require up to 15% travel
- Strong, independent problem-solving and troubleshooting skills, with the drive to challenge scientific direction
- Experience with process modeling and application of process analytical tools
- Ph.D. in Chemical Engineering and 5+ years of experience supporting process development optimization, scale-up, and commercialization
- B.S. / M.S. in Chemical Engineering, and 8+ years of experience supporting process development optimization, scale-up, and commercialization
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.