Senior Principal Scientist, Process Development
Boston, MA /
Research and Technical Operations – Technical Operation - General /
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 an accomplished organic chemist for leadership role as a Senior Principal Scientist in our Process Development group reporting directly to our head of Process Development. The Senior Principal Scientist will drive small molecule process development with their deep expertise in scalable API synthetic process chemistry. This is a unique opportunity to lead process development activities from the discovery chemistry interface (form selection and toxicology batch production) through factory implementation (commercial synthetic route) for Cerevel’s Neuroscience programs. Cerevel’s internal laboratory capabilities spanning chemistry, analytical, and formulation provide excellent tools as we guide external partners in development and production of our molecules. This is an opportunity to be a scientific and program leader as part of a well-funded, growing, and collaborative Technical Operations department.
Key Responsibilities
- Lead the design, planning, and execution of multi-step organic syntheses of small molecules as a member or leader of cross-functional development teams.
- Lead the planning, execution, and oversight of the scale-up of API from laboratory to pilot or commercial scale in accordance with cGMP regulations.
- Lead 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 quality investigations or events and resolve them in a timely manner.
- Independently ensure the selection of appropriate synthetic routes, pharmaceutical forms, and compound properties for development and scale-up of drug substances.
- Author and review drug substance sections for regulatory filings, such as INDs, NDAs, IMPDs, and other regulatory reports.
- Efficiently design and develop high-quality, cost-effective chemical processes for drug substance.
- Mentor, lead, and guide junior process chemists.
- Collaborate with internal groups such as Medicinal Chemistry, Analytical Development, Formulation Development, Supply Chain, Quality, and Regulatory across the discovery through development cycle.
Required Qualifications
- A minimum of 8 years’ relevant work experience post-Ph.D.
- Expertise in small molecule process development from early phase route scouting, FIH batches, to large scale kilogram deliveries and batches supporting registrational stability studies.
- Synthetic route scouting and development, process optimization, and scale-up processes toward late-phase clinical development.
- Hands on crystallization experience and working knowledge of solid polymorphic screening and the criticality of crystal form to drug development.
- Technology transfer and management of process development and batch execution at CMO partners.
- The ability to collaboratively execute rugged potential genotoxic impurity assessments with Toxicology and Regulatory partners.
- Experience in the preparation of reports supporting for regulatory filings such as INDs and IMPDs as well as NDAs.
- Management of on-time API deliveries for drug safety studies, formulation development, and preclinical studies.
- Working knowledge of the a wide range of analytical techniques such as but not limited to HPLC, GC, LCMS, NMR, TGA, DSC, XRPD, etc.
- Knowledge ofcGMPs, ICH guidelines, and regulatory body requirements for the manufacture of drug substances for clinical development and commercial production.
- May require up to 10% travel.
Desired Qualifications
- Hands-on experience with 50+ kg deliveries and manufacture of batches supporting registrational stability studies.
- Experience authoring regulatory documents such as IND, IMPD, and NDA.
- Experience working for a sponsor company in a CMC setting and setting specifications for raw materials, intermediates, and drug substances.
- Desire to work in a fast-paced, dynamic environment.
- Desire to impact internal lab-growth and capabilities.
- A high degree of autonomy with ability to define and implement strategy.
- Strong problem solving and trouble shooting skills.
Education
- Ph.D. in Organic Chemistry
Company COVID-19 Vaccination Policy
- The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law
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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.
