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    Senior Scientist, Analytical Development - Boston, United States - Cerevel Therapeutics

    Cerevel Therapeutics
    Cerevel Therapeutics Boston, United States

    3 weeks ago

    Default job background
    Full time
    Description

    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

    The Senior Scientist will have significant experience in analytical method development, analytical characterization, and control with an emphasis on late clinical-stage to commercial development. The Senior Scientist reports to the Analytical Lead within Late-phase and Commercial CMC, and they will provide analytical expertise in drug substance and drug product analytical development for small molecule, post-proof of concept through long-term commercial development and manufacturing. They will work closely with colleagues across pharmaceutical development to best leverage Cerevel's internal development capabilities including process chemistry, analytical, and formulation development labs, instruments, and equipment. Additionally, they will identify and manage external partners for late-phase method development as well as late-phase through long-term commercial analytical testing and characterization across Cerevel's portfolio of late-stage programs. The Senior Scientist will grow as a subject matter expert both within and outside the department and will help drive of pharmaceutical development as part of this growing, dynamic team.

    Key Responsibilities

    • Guide and drive analytical method development, implementation as well as drug substance and drug product characterization and control for Cerevel's late-stage to commercial programs
    • Provide technical support and day-to-day management of outsourced drug substance and drug product method development activities with CMO partners
    • Manage analytical testing activities including in process, drug substance and drug product release testing through review of analytical data
    • Present technical data to cross functional teams and senior management as an expert in analytical driver for Cerevel's late-stage development programs
    • Design, support, and analyze method transfer and validation activities across a portfolio of small molecule, solid oral dosage projects
    • Author and review drug product and drug substance analytical sections for regulatory submissions
    • Support any quality investigations or events and resolve them in a timely manner
    • Train and recruit late-phase and commercial CMC staff
    • Identify and advocate new and emerging technologies in analytical and physical characterization analysis
    • Drive the specification setting process from API starting materials to drug product for late-stage and commercial projects
    • Partner with Chemical Process Development and Formulation Development staff to assess and support drug substance and drug product characterization and retest/shelf-life setting

    Required Qualifications

    • Demonstrated expertise in late phase and commercial analytical development, method transfer, and stability program design and execution
    • Experience with managing external testing laboratories during late clinical-stage pharmaceutical development
    • Subject matter proficiency in the analytical development of oral formulations with experience in discriminating dissolution test method development, HPLC, GC, titrations, spectroscopic methods, and physical characterization techniques such as X-ray powder diffraction, DSC, and TGA
    • Knowledge and the ability to interpret and draw conclusions from data from analytical techniques employed across drug substance and drug product development
    • Ability to troubleshoot analytical method and testing issues, determine causes and possible solutions
    • Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment

    Education

    • Ph.D. (or equivalent degree) in relevant discipline and 2+ years relevant work experience
    • B.S. / M.S. in relevant discipline and 8+ years relevant work experience

    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.

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