Common Knowledge & Skills
· Emerging internal scientific thought leader with strong technical expertise in analytical development.
· Applies in-depth scientific knowledge and critical thinking to resolve complex analytical development problems.
· Ability to translate established strategy and priorities into operational and tactical plans.
· Strong leadership, coaching, employee development, and influencing skills.
· Excellent written, verbal, presentation, problem-solving, and analytical skills.
· Ability to collaborate effectively across functions and within a matrix environment.
· Demonstrated ability to manage multiple projects, priorities, and external relationships.
· Learning agility and willingness to evaluate innovative scientific approaches and technologies.
Job-Specific Knowledge & Qualifications
· Strong knowledge of analytical method development, qualification, validation, transfer, and troubleshooting.
· Strong knowledge of ICH and FDA guidance related to analytical methods, stability, CTD, and CMC regulatory submissions.
· Experience evaluating analytical data, technical documents, and regulatory submissions.
· Knowledge of cGMP requirements and CMC regulatory expectations supporting drug substance and drug product development.
· Experience managing analytical activities with external CROs/CMOs.
· Knowledge of physicochemical characterization of APIs, drug substances, drug products, and related compounds.
· Understanding of formulation and process development and their relationship to analytical development.
· Previous people leadership and/or demonstrated leadership of scientific teams, projects, or external partners required.
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Bachelors degree in Chemistry, Pharmacy, or related scientific discipline AND 10+ years of applicable pharmaceutical industry experience OR
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Master’s degree in Chemistry, Pharmacy, or related scientific discipline AND 8+ years of applicable pharmaceutical industry experience OR
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PhD in Chemistry, Pharmacy, or related scientific discipline AND 6+ years of applicable experience
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Strong knowledge of analytical method development, qualification, validation, transfer, and troubleshooting
•
Strong knowledge of ICH and FDA guidance related to analytical methods, stability, CTD, and CMC regulatory submissions
•
Experience evaluating analytical data, technical documents, and regulatory submissions
•
Knowledge of cGMP requirements and CMC regulatory expectations supporting drug substance and drug product development
•
Experience managing analytical activities with external CROs/CMOs.
•
Knowledge of physicochemical characterization of APIs, drug substances, drug products, and related compounds
•
Understanding of formulation and process development and their relationship to analytical development
•
Previous people leadership and/or demonstrated leadership of scientific teams, projects, or external partners required
•
Emerging internal scientific thought leader with strong technical expertise in analytical development
•
Applies in-depth scientific knowledge and critical thinking to resolve complex analytical development problems
•
Ability to translate established strategy and priorities into operational and tactical plans
•
Strong leadership, coaching, employee development, and influencing skills
•
Excellent written, verbal, presentation, problem-solving, and analytical skills
•
Ability to collaborate effectively across functions and within a matrix environment
•
Demonstrated ability to manage multiple projects, priorities, and external relationships
•
Learning agility and willingness to evaluate innovative scientific approaches and technologies