Job Purpose: Briefly state the job's primary purpose in two or three sentences.The purpose should describe how the job supports Perrigo.

Provide leadership in the development, technology transfer and technical support as needed for commercialization activities in assigned projects or product categories by directing the work of project teams and individual contributors to support the company's First-to-File and First-to-Market strategy in addition to the rest of the product portfolio such as OTC monograph products, 505 b2setc. Ensures that scientific and professional standards are maintained throughout the department's processes and activities.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.

Knowledge, Experience and Education:

Leading edge knowledge of the principles and practices of pharmaceutical development in both solid and preferably other dosage forms such as liquid and topical dosage forms. Demonstrated capability in design, execution and documentation of robust and reliable development processes.

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. 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

These skills are normally acquired through completion of a Master's degree in Pharmaceutical Sciences combined with 17+ years of research experience in the pharmaceutical industry or a doctoral degree Pharmaceutical Sciences combined with 12+ years of research experience in the pharmaceutical industry; coupled with a minimum of 8 years of progressive leadership experience in people management roles.

Major Duties:

- Establish priorities, monitor the progress of all assigned projects, allocate resources, and ensure that projects meet milestones and deadlines for new dosage forms interfacing to facilitate - First-to-File- and - First-to-Market- corporate goals.

- Direct and manage product/process development and commercialization technology transfer activities (as a technical leader of junior and senior level scientists and managers) for new dosage forms interfacing with Analytical Research & Development scientists and other multidisciplinary functions to ensure products can be produced with scientific rigor in a manner that is efficient, safe and compliant with FDA and company regulatory standards.

- Represent Formulation in product evaluation teams and to internal and external groups.

- Monitor trends in new product development and professional standards, anticipate scientific needs, and champion the modification of policies to better meet department and business needs. Implement processes that enable the group to meet tight timelines and utilize limited resources. Challenge the status quo regarding depth of knowledge on products and methods, current technology, and colleague development. Provide creative tools and expertise to aid in meeting business challenges and strategies, including ad-hoc technical teams.

- Ensure that the department operates to maintain a state of controlin coordination with QA. Participates in quality issue resolution in development phase as part of cross-functional team. Resolution of issues conducted in a multi-regulatory environment in order to meet FDA as well as Indian regulations

- Hire, train and evaluate performance of subordinate technicians and scientists, ensuring their development and maintaining quality and compliance standards.

- Provide advice to FR&D leadership in evaluating new products or due diligence activities as requested.

Organization Structure and Functions:Please attach organizational chart and indicate the number of reporting relationships (do not include temporary or contract employees).

This position supervises a total team size of 6 - 12 to 25 -12 managers, scientists and technicians.

Additional Information:

Principle Challenges:

Typical Problems:

Interpreting complex experimental data to develop formulation recommendations is a common challenge. Ensuring the accuracy of records of research outcomes and maintaining compliance with regulatory requirements and the company's operating standards are also typical problems. Managing changes in the life cycle of each project is also an on-going challenge. Ensuring professional development of subordinate scientists and technicians by assigning appropriately challenge projects and monitoring progress is an on-going challenge.

Most Complex Problems:

Identifying solutions to formulation development challenges or changes as result of in vitro or in vivo studies and evaluating their feasibility to recommend manufacturing processes is a complex challenge.

Decision Making Authority:Identify the types of decisions that this job has the authority to make on its own as well as those that must be referred to others.In both cases, include authority for decisions regarding issues of policy and procedure, administrative matters, and personnel (hiring, firing, salary increases, etc.).

Typical decisions:

Develops critical judgment as decisions require solutions to complex problems, which could cause significant delays in project timelines and result in considerable allocation of resources. Uses high-level scientific judgment to adapt and create techniques using prior work experience; proactively consults colleagues and management to ensure alignment of judgment. The incumbent evaluates the quality of research data and provides feedback and direction to subordinate teams to ensure scientific processes are robust and defensible. The incumbent assigns projects and prioritizes work to ensure project deadlines are met.

Other decisions:

Final responses to regulatory agencies are reviewed with management colleagues as necessary. Significant problems which impact project deadlines or costs are reviewed with the Director of Project Management.

Financial Dimensions: Provide financial dimensions about the position that will best describe or measure its size, influence, or effect on the business.Think in terms of items/areas that the job must manage, control, influence, or impact in a measurable way. Enter - not applicable- if the financial impact of the job cannot be determined.

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