Senior Manager/Associate Director - Formulation R&D - United States
Provide leadership and technical direction to facilitate product development and commercialization activities of new or reformulated products by directing the work of project teams and individual contributors to support the company’s First-to-File and First-to-Market strategy.
- Leading edge knowledge of the principles and practices of pharmaceutical development in both oral solid and liquid dosage forms.
- Establish priorities, monitor the progress of all assigned projects, allocate resources, and ensure that projects meet milestones and deadlines for new product development projects.
- Work across multi-departmental/functional and global groups or teams to provide leadership, technical expertise and an enthusiasm to promote an environment of continuous improvement.
- Direct and manage product/process development and commercialization activities (as a technical leader of junior and senior level scientists and managers) for new immediate release and modified release solid oral dosage and liquid oral dosage forms interfacing with Analytical Research & Development scientists to ensure products can be produced with scientific rigor in a manner that is efficient, safe and compliant with FDA and company regulatory standards.
- Considerable breadth and depth of problem solving experience is necessary. Excellent communication skills and the ability to represent the department to both internal and external constituencies are required.
- Liaison between R&D and internal partners (i.e., Technical Operations, Manufacturing, Quality, Marketing, Business Development, etc.) and external partners (i.e., third party contractors) depending on project needs and requirements.
- Familiarity with project management methodology, demonstrated ability to lead project teams and mentor other scientists are required.
- Demonstrated ability to develop and perform critical review and approval of a wide variety of technical and scientific documents, including but not limited to SOPs, product development reports, technology transfer reports, master batch records, process validation and regulatory filing documents (i.e., Common Technical Documents (CTD), Quality Overall Summary (QOS)).
- Demonstrated ability to make presentations before project teams and senior management.
- A thorough working knowledge of cGMP, other Regulatory agencies/authorities, and ICH guidance documents is essential. Good leadership skills and demonstrated ability to manage people are essential. The ability to lead teams to help achieve departmental objectives and project timelines is required.
- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with 18+ years of research experience in the pharmaceutical industry,
- Master’s degree combined with 15+ years of relevant research experience in the pharmaceutical industry.
- PhD degree combined with up 12+ year of relevant research experience in the pharmaceutical industry.
- 8 +years of progressively responsible experience in research management in a regulated environment.
An Equal Opportunity Employer - M/F/D/V