Job Description

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Position Title:	Director Formulations & Process Development
Department:	Product Development
Reports To:	VP Product Development
FLSA:	Exempt
Grade:	A1
Date:	2008/10/31

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Purpose and Scope

Provide management and leadership for all activities relating to formulation and process development while ensuring compliance with all TOLMAR's cGMP, SOP's and FDA regulations.

Essential Duties & Responsibilities

• Direct teams in the development of product formulations, which meet the clinical and commercial requirements for the finished product.
• Define and manage the scope of projects and ensure projects are aligned with Product Development decisions and strategies.
• Direct and resolve technically orientated investigations related to product transfer initiatives.
• Define plans and timelines for implementation plans, evaluating and enhancing process optimization and process improvements initiatives that will include process yield, product throughput timing and trending for quality analysis.
• Direct a staff composed of individuals at various scientific and engineering levels. Organize staff to provide proper task execution and adherence to timelines while maintaining a team environment. Responsible for staff performance assessment, coaching and aiding staff in their career development.
• Collaborate with functional areas including analytical, manufacturing, regulatory, clinical, quality and project management staff to ensure the successful transfer of processes and information with flawless execution to meet project deliverables and milestones.
• Ensure that all operations and functions are in full FDA and cGMP regulatory compliance, and staff is properly trained.
• Prioritize projects to meet timelines within formulation and process development groups.
• Work as part of the leadership team to help meet departmental goals, initiatives, and customer requirements.
• Meet objectives while managing spending, capital and labor to budget.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Expert knowledge of current Good Manufacturing Practices (cGMP), FDA and International regulations.
• Demonstrated solid technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Excellent interpersonal, communication, problem-solving and organizational skills.
• Proven skill in effective management and leadership.
• Effective skill in troubleshooting, process optimization and scale-up.
• Excellent oral and written communication skills demonstrated through interactions internally and externally.
• Ability to manage multiple projects.

Education & Experience

• Bachelor's, Master's or PhD degree in a scientific discipline.
• Related pharmaceutical experience combined with Bachelor's degree 10+ years: Master's 8-10 years; PhD 5+ years.

Working Conditions

• Working conditions are typical for an office environment.
• Laboratory setting. Will be exposed to solvents, biohazardous materials and pharmaceuticals.