Search jobs > Garland, TX > Associate analytical
A company is looking for an Associate Director, Analytical Sciences to oversee strategic analytical aspects of drug development and manufacturing activities.
Key Responsibilities : Define and execute analytical strategy for late-stage development candidatesParticipate in method optimization and ICH method validations for drug substance and drug productAuthor and review regulatory submission documents and relevant change controlsRequired Qualifications : BS or equivalent in chemistry or related discipline with 10-15 years of relevant industry experience, or a PhD with 3-5 years of experienceStrong understanding of cGMP / ICH regulations and USP GuidelinesExpertise in late-phase small-molecule drug substance and drug product analytical supportTechnical leadership experience with CROs and CDMOsMastery of current ICH guidelines and related industry practices
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