Cerevel Therapeutics Boston , MA 02298
Posted 4 weeks ago
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
We are seeking an excellent individual for a Principal Scientist position within the DMPK group to support regulatory bioanalytical work. The successful candidate will have a strong experimental background with an established track record of hands on regulatory bioanalytical assay support and technical problem solving. The successful candidate ideally has experience supporting projects with CROs in drug development. Experience in regulated bioanalysis to support GLP/GCP studies is also a must. At the senior level, this person will guide assay development and troubleshooting as well as analytical method problem solving using LC- MS/MS, validating and supporting GLP/GCP sample analysis in different biological matrices across the discovery & development projects, and have experience for filing IND and NDA.
Key Responsibilities
Supervise, manage, and strategic planning on objectives and prioritization with BA CROs to deliver robust and reliable bioanalytical assays
Lead development and technology transfer of BA methods to CROs in US and externally
Lead scientific review and provide instructions on bioanalysis at CROs to provide quality data/reports within specified timelines
Attend project meetings and manage timelines for coordinating BA and CRO work
Responsible for review and approval of data/report from both BA and CRO labs in coordination with the CRO BA PI and PM
Contribute to the preparation of bioanalytical sections of IND/BLA documents
Contribute to addressing questions and inspections from the regulatory agencies
Provide bioanalytical support and collaborate with Tox Group in GLP Tox studies
Strong knowledge with latest FDA/EMA/ICH guidelines
Professionally network with bioanalytical scientists in other pharmaceutical companies to be current with standard practices and regulatory issues facing bioanalytical development
Integrate quality standards to ensure data of the highest quality (e.g., GLP and cGCP compliance, accuracy, precision)
Required Qualifications
At least PhD with5 to 8 years; or MS/BS with 8 to 12 years of experience in leading and managing a bioanalytical function within a corporate setting
Experience in the application of high throughput and automated approaches for various extraction procedures
Persuasive written and oral communications skills
Demonstrate success in technical proficiency, scientific creativity, and collaboration with others and independent thought
Scientific know-how: widely recognized as an expert that maintains high level of professional expertise through familiarity with scientific literature
This candidate should be a driver of innovative scientific research and development on bioanalysis
Drive the scientific rigor and integrity of the data collected as well as the derived conclusions
Report and communicate scientific ideas and results to senior leaders as needed
Present and publish findings to project teams/Cerevel/external scientific community
Ensure data integrity and data accessibility through the Cerevel R&D data domains
Ensure compliance with Cerevel Values and Policies
Experience in writing and reviewing validation/bioanalytical reports for regulatory filing
Desired Qualifications
A minimum of PhD with5 to 8 years; or MS/BS with 8 to 12 years of industry experience in conducting bioanalytical research and development, validation, and sample analysis for nonclinical/clinical assays
Expert in the bioanalytical application of liquid chromatography, and mass spectrometry for small molecules compounds
Previous experience with automated workflows and LC-MS/MS analysis
Identify, investigate and implement new DMPK technologies
Work closely within DMPK, Cross functional groups and subject matter experts to ensure that in vitro/in vivo DMPK technologies and science are relevant for project teams and portfolio deliverables
Education
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.
Cerevel Therapeutics