Job Description
The position is responsible for technical leadership of analytical development within the CMC function across Scorpion's portfolio. Analytical Development has responsibility for analytical activities from late-stage Discovery (lead optimization, development candidate nomination) through early-stage clinical development for small molecule programs. The candidate will ensure success on all drug substance and drug product deliverables by leveraging internal and external resources. They will also be responsible for strategic and scientific alignment of analytical development activities with the overall program needs.
The candidate should have a proven track record of leadership, mentorship, and technical achievement working within a cross-functional matrix environment. They should be a leader in the scientific community, capable of effectively managing technical issues with their function and providing expertise throughout the company. This individual should actively maintain and champion state-of-the-art scientific and technical knowledge, implementing creative ways to solve challenging problems for new and ongoing projects.
Qualifications
- PhD in chemistry, chemical technologies or related area with 15+ years relevant experience in analytical development roles within the pharmaceutical industry
- Expertise in phase-appropriate small molecule analytical method development and validation
- Extensive knowledge of advanced analytical principles and theories; expertise in analytical laboratory techniques for drug substance and drug product and application of control strategies through all stages of development
- Knowledge and experience of pre-development activities - pre-formulation, solid state, formulations for animal studies
- Demonstrated ability to set clear and measurable goals, managing tasks and resources
- Excellent written and verbal communication skills, organization, and planning skills and a high level of technical aptitude and creativity
- Expertise in all relevant Quality and Regulatory guidelines with the ability to provide mentorship, oversight and review of all relevant Analytical Development source documents for regulatory submission
- Ability to implement new technologies for development programs
- Ability to develop and maintain project plans for internal and external analytical resources, timelines, and budgets
- Proven track record of building strong collaborations and relationships with external CDMOs, internal technical leads and project teams