Job Description
Our client is seeking an Associate Director to join our Technical Operations team. The Associate Director Development will provide scientific and technical leadership at various stages of drug development including analytical method assessment, development, transfer, validation and troubleshooting of methods.
You will lead/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 Process Development.
Responsibilities:
- 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
- Troubleshooting 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 of analytical methodologies for drug substance and drug product
- Experience in regulatory requirements for pharmaceutical products
- Experience in managing contract analytical organisations is highly desired
- Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills.
- Excellent written and verbal communication skills with the ability to multi-task.
- Demonstrated troubleshooting and problem-solving skills
- Up to 25% travel required
- Advanced degree in Chemistry, Pharm. Sci., Biochemistry, or related field, or equivalent combination of education and work-related experience required
- 6-10 years direct experience analytical development, preferably in a pharmaceutical/biotech industry.
For further information on this Associate Director, Analytical Sciences position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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