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Sr. Scientist II LCMS

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Experience: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline with 3+ years of industry experience; or M.S. with 6+ years of relevant experience.
Posting language: English

Lead development, optimization, transfer, and validation of LC-MS/MS assays for quantification of small molecules and metabolites in biological matrices.
Consistently delivers high-quality bioanalytical methods, study support, and scientific deliverables that meet established timelines and project milestones.
Provide bioanalytical support for pharmacokinetic (PK), toxicokinetic (TK), and clinical studies.
Design and execute complex studies while ensuring compliance with GLP, GCP, and regulatory guidance.
Review, interpret, and present bioanalytical data to project teams and senior management.
Maintains inspection-ready documentation and ensures compliance with applicable regulatory, quality, and data integrity requirements, with no significant audit or inspection findings attributable to assigned activities.
Serve as a subject matter expert in mass spectrometry and bioanalytical science.
Collaborate with DMPK, Clinical Pharmacology, Toxicology, Regulatory Affairs, and Quality functions.
Manage activities performed at CROs and evaluate study deliverables for scientific quality and regulatory compliance.
Author and review study plans, validation reports, SOPs, and regulatory submission documents.
Mentors and develops junior scientists, fostering technical excellence, knowledge sharing, and a collaborative scientific culture within the organization.

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Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline with 3+ years of industry experience; or M.S. with 6+ years of relevant experience.
Extensive experience in LC-MS/MS bioanalysis of small-molecule therapeutics.
Strong knowledge of FDA and ICH bioanalytical method validation guidance.
Demonstrated ability to lead scientific projects and solve complex analytical challenges.
Excellent written, verbal, and presentation skills.

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