Senior Director / Director, Analytical R&D
Technical and managerial leadership in analytical R&D inthe company, directed towards Drug Substance development for regulatory submissions and approvals. This includes oversight of analytical method development, validation and transfer to commercial sites and vendors and supporting regulatory filings including investigational new drugs (INDs)/investigational medicinal product dossier (IMPDs) and new drug applications (NDAs). The Director of Analytical R&D will be directly responsible for a team of senior and associate level scientists. The position is accountable for delivering analytical methods that meet our commitment to world class supply, are phase appropriate and adhere to the highest scientific standards. This position will lead Analytical Sciences groups ensuring compliance (cGMP-GLP) and stressing the competencies of productivity, quality, and teamwork in accomplishing company goals.
The successful candidate requires the ability to collaborate in an accelerated, integrated, multidisciplinary team environment. Research and Development experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including separation technologies(HPLC / SFC/ GC / CE / IC / LCMS / GCMS / UPLC), spectroscopic techniques (NMR, MS, UV-VIS / IR / Fluorescence / Raman) and classical wet chemistry techniques.
- Develop, drive, and maintain strategic internal partnerships
- Enhance/introduce technical capabilities and competencies in analytical development of processes for the manufacturer of intermediates and APIs
- Establish processes and extend scope of influence in global development efforts
- Provide leadership to multi-disciplinary meetings and project teams.
- Develop budgetary requirements for projects and laboratory operations, manage and adjust activities to operate within budgetary goals
- Identify, develop and position staff for new initiatives and for greater roles and responsibilities in the company
- Requires Ph.D. Degree or equivalent with 7+ years of pharmaceutical industry experience
- Requires a broad understanding of pharmaceutical sciences, product development, and current international regulatory requirements
Requires the ability to influence others and communicate effectively, both written and orally
- Requires the ability to manage aspects of the Analytical Department operations – personnel, financial, organizational
- Requires the ability to motivate, lead, and develop departmental staff from an organizational as well as technical perspective
- Proposes and opens up new areas of R&D creatively and independently.
- Proposes and implements new R&D goals
- Requires the ability to lead and manage multidisciplinary teams.
- Strength in delivering results on firm deadlines in support of development and commercial filing.
- Entrepreneurial spirit is a plus.
- Excellent verbal and written communication
- Critical thinking
- Problem solving
- Active listening
- Out-of-the-box thinking
- Knowledge of technology trends
- Knowledge of regulatory requirements