Lead Scientist in Pharmaceutical Analytics
2 months ago
Position Overview
Job Purpose
Serve as a technical authority to enhance process and formulation development within a CMC framework; Facilitate coordination of analytical activities across various functions, both globally and locally, as well as with external collaborators.
Key Responsibilities
Major Duties
-- Act as the analytical representative in cross-functional project teams. Spearhead analytical initiatives to support programs from late-stage discovery through early clinical phases.
-- Conduct analytical method development (including assay/impurity, chiral purity, etc.), release testing, and impurity characterization to aid API process development.
-- Assess the physicochemical characteristics of API and drug products, such as particle size, dissolution, and content uniformity, to support solid oral dosage forms.
-- Establish specifications for both API and drug products with appropriate justifications.
-- Draft analytical documentation including test protocols, method validation reports, method transfer protocols, stability reports, and release certificates of analysis (CoA), among others.
-- Oversee collaborations with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) for outsourced activities. Supervise analytical method development, validation, release testing, and stability studies conducted at CROs/CMOs.
-- Prepare analytical sections of documentation for drug substances and drug products to support regulatory submissions.
Required Qualifications
A degree in analytical chemistry or a closely related discipline with over 2 years of relevant experience in the pharmaceutical sector, or a Master’s degree in analytical chemistry or a related field with 5-10 years of industry experience.
Leadership Skills
Technical proficiency, sound decision-making, effective collaboration with cross-functional teams, and strong independent problem-solving abilities.
Essential Competencies
Comprehensive understanding of advanced analytical theories and technologies, along with practical experience in operating, calibrating, maintaining, and troubleshooting a variety of analytical instruments (HPLC, GC, SFC, IC, LCMS, dissolution, etc.).
Expertise in analytical testing method development, validation, stability assessments, and impurity identification to support both drug substance and drug product development.
Additional Skills
Experience in dissolution method development and in vitro-in vivo correlation (IVIVC) modeling for solid oral drug products is advantageous.
Familiarity with ICH guidelines and a solid understanding of cGMP and GLP laboratory operations.
Exceptional written and verbal communication skills in English, with the ability to collaborate effectively within a diverse team in a dynamic environment.
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