EPM Scientific are looking a top level candidate to fill a vacancy as a Director of Analytical Development for a client of ours based near Alachua, Florida. This will be a fully ON SITE position and the correct candidate will be prepared to work 5 days a week at location. The Director, Analytical Development (AD) is responsible for setting strategy for the analytical development function and executing the strategy to meet all applicable regulatory guidance. The Director will lead efforts to develop assays through transfer and validate assays for the characterization of viral vector biologics in support of the Company's product development projects. This includes both internal as well as with external vendors and contractors.
Role: Director, Analytical Development
Location: On Site (Alachua, Florida)
Contract: Temp to Perm
Requirements
- Develop and manage timelines and budgets for AD scopes of work (SOWs) and activities consistent with corporate goals and needs
- Work with business development and project management to prepare proposals for customers for analytical work which meet customer needs, have realistic timelines and are appropriately priced
- Meet with customers to present plans and results of work done by the analytical team
- Work with R&D and Regulatory Affairs to facilitate internal assay development and qualification for early phase programs in support of customer needs
- Design, implement and report material comparability studies consistent with regulatory guidelines
- Support Regulatory by compiling data, authoring and reviewing IND or similar sections as requested
- Oversee all analytical development activities in compliance with International Conference on Harmonization (ICH) guidelines to support characterization of raw materials and AAV viral vectors and process-related impurities in support of preclinical and clinical pipeline programs
- Oversee assay transfer to QC or at contract testing organizations used for release testing of viral vectors used as raw material or final product in GLP animal and GCP human clinical studies
- Work with QC/QA to ensure optimization and qualification/validation internally is successfully completed in support of clinical material testing and release and/or commercial advancement of relevant AAV therapeutic programs
- Manage direct reports, including setting individual goals and annual reviews aligning with corporate expectations
- Other duties as assigned
- This job description is subject to change at any time
Educational Qualifications
- Masters in a scientific or engineering discipline
- PhD preferred
Additional Qualifications
- A Master's degree and a minimum of ten (10) years of experience, or PhD and a minimum of eight (8) years of experience. Experience must be in a biotechnology or pharmaceutical company AD/QC environment, gene therapy highly desirable
- Strong experience/knowledge of assay development, including previous experience validating assays
- Excellent organization and planning skills
- In-depth understanding of regulatory requirements for the development, qualification and validation of assays employed in the release of human clinical material
- Strong interpersonal skills and previous experience managing AD/internal QC analysts
- Working knowledge of GLP, GMP, ICH and Quality Systems requirements for biologic products
- Excellent communication skills, both written and verbal
Benefits
- Annual bonus
- 401k
- Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances
- 20 days PTO
- 5 days Sick leave
- 6 weeks Parental Leave