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
Reporting to Head of Technical Operations CMC, the Director - Analytical Development is an accomplished technical expert in the diverse techniques, instruments, and methods applied to analytical characterization across API starting materials, through to intermediates, on to drug substance, and finally drug product for small molecule pharmaceutical development programs. This leader will be a driver of technology advancement and execution of analytical development activities occurring in our internal labs and across our partner network of CDMOs and analytical laboratories during the pre-clinical through clinical development stages. The Director will lead and develop a group of highly capable scientists while tackling challenging analytical method development and data interpretation problems in a fast-paced, growing company. During the clinical development stage, they may lead, sit on, or mentor CMC teams supporting activities across pharmaceutical development. They will drive stability strategy through innovative and risk-based stability assessment approaches. This functional lead will also provide input and guidance on regulatory strategies and work closely with Quality Assurance. Additionally, they will partner with finance and program team leaders to develop thoughtful functional area budgets. The Director will work closely with their peers in Chemical Process Research, Formulation Development, Clinical Supplies, and Late-stage CMC & Commercial to continue to build Technical Operations at Cerevel and deliver important medicines to patients.
Key Responsibilities

• Work with their team and external partners to develop methods and control strategies for Cerevel's portfolio of pre-clinical and clinical molecules
• Deliver broad expertise in small molecule analytical development for drug substance and drug product while working closely with chemical process research and formulation development to drive clinical programs
• Drive and own the specification setting process across drug substance and drug product
• Propose and support retest dates, shelf life, and expiry periods
• Develop, mentor, and manage staff
• Lead cross-functional CMC teams for pre-proof-of-concept programs
• Drive analytical development activities for drug substance and drug product internally and with partner organizations
• Manage CDMOs including selection, planning and reviewing technical execution, ensuring budget and timelines are achieved, and data driven decisions for the project are made
• Develop risk mitigation strategies to ensure issues are managed and program milestones are achieved
• Partner to define regulatory strategies and author and review CMC-related sections for regulatory filings
• Execute within current Good Manufacturing Practice requirements and guidance ensuring Quality is built into every activity

Required Qualifications

• A PhD and a minimum 10 years of experience of relevant small molecule analytical development or MS/BS degrees with additional industry experience directly relevant to small molecule analytical development
• Demonstrated experience in leading CMC teams
• Experience in managing CDMOs, leading GMP activities and ensuring drug supply for pre-clinical and clinical studies
• Demonstrated ability to identify and deliver fit-for-purpose and technically sound analytical methods for drug substance and drug product
• Ability to lead internal and external teams
• Experience setting specifications for drug substance and drug product
• Experience setting up drug substance and drug product stability programs and interpreting the data to recommend rest or shelf-life periods
• Demonstrated ability to manage and develop scientific staff
• Understanding of Regulatory and phase-appropriate Quality requirements governing GMP analysis and control for drug substance and drug product
• Strong project management, interpersonal, and communication skills
• Ability to partner with diverse business functions to enable high quality outcomes
• Proficient in developing and executing regulatory strategies and authoring and reviewing of the CMC sections of dossiers
• Experience with solid oral dosage forms both immediate and modified release

Desired Qualifications

• Desire to work in a fast-pace, dynamic environment
• Technical depth across the functions that contribute to pharmaceutical development: Process Chemistry, Formulation and Analytical Development
• Excellent communication and presentation skills
• Team player; experienced at developing talent
• A high degree of autonomy; takes accountability for work
• Experience with identification and process control of potential genotoxic impurities
• Familiarity with solid-state characterization and control as it relates to drug substances used in solid oral dosage formulations

Education

• Ph.D in Chemistry or Chemical Engineering or related disciplines. MS degree candidates with substantial direct experience in CMC will be considered

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.