The Associate Director Analytical Development will provide scientific and technical leadership for analytical development at various stages of drug development including material characterization, analytical method assessment, development, transfer, validation and troubleshooting of methods.
The Associate Director Analytical Development will lead analytical activities for research/early development programs, late stage development programs, and commercial products. Activities may be performed internally or with external vendors. Other responsibilities will include cross-functional team membership and/or leadership, authoring and/or reviewing method validation protocols and reports, technical reports, authoring or reviewing CMC aspects of regulatory dossiers and participation in department or functional initiatives.
The Associate Director Analytical Development will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring all methods are understood, robust, efficient and in control.
The role is both project and operations orientated. It shall require an ability to drive and deliver multiple projects concurrently.
Reporting into the Snr Director Analytical Development, this is an opportunity to join the Small Molecule Development team.
- Lead analytical method development, validation, transfer and stability evaluations, supporting early stage, late stage and commercial products
- Represent analytical development on cross-functional CMC product development teams
- Ensure that all analytical methods are in line with all applicable regulations, policies, guidelines and procedures
- Vendor management and oversight of workflow, progress and milestones at vendors
- Trouble-shooting of analytical methods
- Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences
- Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings
- Ensure a smooth transfer of analytical technologies to contract sites
- Keep current with developments in analytical methodologies and make recommendations for implementation of new methods/equipment.
- Provide technical assessment during product acquisition due diligence as required
- Strong record of achievement in drug substance development and manufacturing.
- Over 10 years direct experience analytical development, preferably in a pharmaceutical/biotech industry.
- Broad experience in analytical sciences supporting early stage, late stage and commercial products
- Direct experience with analytical method development, validation, transfer and stability evaluations
- Demonstrated technical proficiency of analytical methodologies for drug substance and drug product
- Experience in regulatory requirements for pharmaceutical products
- Experience in managing contract analytical organizations is highly desired
- Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills, including ability to lead and drive performance of cross-functional teams.
- Excellent written and verbal communication skills with ability to multi-task.
- Demonstrated troubleshooting and problem solving skills
- Demonstrated track record of delivering positive results on a consistent basis.
- Proven project management skills for technical programs
- Experience in managing and maintaining budgets desirable
- Advanced degree in Chemistry, Pharm. Sci., Biochemistry, or related field, or equivalent combination of education and work-related experience required
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