Our Client is an international biopharmaceutical company looking to recruit an Associate Director Analytical development, the role will provide scientific and technical leadership at various stages of drug development including analytical method assessment, development, transfer, validation and troubleshooting of methods.
The Associate Director Analytical development will support 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, authoring and/or reviewing method validation protocols and reports, technical reports, and supporting CMC aspects of regulatory dossiers.
The position reports to the Senior Director of Analytical Development.
- Support early stage, late stage and commercial products in analytical sciences
- Lead analytical method development, validation, transfer and stability evaluations
- 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
- Support and 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.
- 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 in 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 the ability to lead and drive performance of cross-functional teams.
- Excellent written and verbal communication skills with the ability to multi-task.
- Demonstrated troubleshooting and problem-solving skills
- Current knowledge of quality systems and both FDA and EU regulations as they relate to process / product development and manufacturing
- Advanced degree in Chemistry, Pharm. Sci., Biochemistry, or related field, or equivalent combination of education and work-related experience required
- 6-10 years of direct experience in analytical development, preferably in a pharmaceutical/biotech industry.
- Up to 25% travel required.
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