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Director of Analytical Development

Location: Northeast

The Director of Analytical Development is responsible for high-level management of the generation of analytical documentation, and stability services, which support the approval of new products and processes. Responsible for ensuring the organization is operating within an appropriate level of cGMP, HS&E and DEA compliance.

Business Planning

Establish achievable plans and objectives in alignment with corporate strategies and drive projects to conclusion.

Identify and manage significant risk issues to upper-management and provide possible solutions.

Provide strategic planning for department goals.

Drive the compliant use of information technology to support the efficient management of documentation and data.

Organization

Build and maintain an efficient organization to meet current and future needs for the Analytical Development department.

Ensure clear communication of roles within department.

Maintain an SOSD culture throughout the organization. Embed a quality/TQM philosophy.

Support HS&E awareness and culture.

Establish Efficient & Effective Processes

Delivers technical systems and data in a timely manner to meet or exceed business objectives.

Provide acceptable methods to transfer technology to customers and protect intellectual property.

Ensure the appropriate level of documentation throughout the development process in order to provide sound analytical information.

Ensure appropriate resources (people, materials, instrumentation) are available to achieve objectives.

Operating & Financial Performance

Deliver performance targets as agreed. Manage approved capital projects that are delivered on-time and in-full.

Compliance

Ensure that all operations are appropriately compliant with applicable regulations for the work being performed (FDA, DEA, MCA, etc.)

Minimum Experience:7-10years experience in the pharmaceutical industry; at least 4 years experience in a senior management position or equivalent background of education and experience.

Must be highly knowledgeable in regulatory and technical requirements of the pharmaceutical industry, have interacted directly with regulatory agencies, and have a strong management background. Must have the ability to evaluate staffing and equipment needs versus project workload essential. Areas of expertise should include: analytical method development and validation, regulatory requirements throughout development (clinical trials materials, stability, chemistry, manufacturing & controls, preparation for pre-approval inspections) and an in-depth knowledge of at least one scientific field related to pharmaceutical sciences. Must manage multiple high-level priorities and relationships. Must have demonstrated ability to delegate minor tasks. Requires the ability to validate decisions taken at lower levels by utilizing strong analytical, troubleshooting and problem solving. Will be asked on occasion to manage large cross-functional development programs, project management skills are essential. Excellent interpersonal, verbal, and written communication skills are required, with ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision. Must have strong managerial, organization, leadership and analytical skills. Key technical backgrounds: small-molecule chromatography and detection techniques; thermal analysis; USP methods and tests and dissolution techniques.