Principal Scientist, DMPK (Regulatory Bioanalysis)

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

• PhD or MS/BS in Analytical chemistry, pharmaceutical chemistry, or related science