Head of Pharmaceutical Chemical Development

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,000 people and operates in more than 150 countries worldwide. Its 2006 sales were nearly $2.2 billion. Merial Limited is a joint venture between Merck & Co., Inc. and sanofi-aventis.  For more information, please see www.merial.com

 

Head of Pharmaceutical Chemical Development

 

The Head of Pharmaceutical Chemical Development leads all aspects of R&D API development to ensure timely availability of material and data to support registration of new pharmaceutical products. Is responsible for identifying, developing and optimizing efficient manufacturing processes for production of active drug substance to support development, registration, and commercialization of New Chemical Entities (NCE), including pre-formulation assessment, process research, analytical methods (in collaboration with AR&D), characterization, and stability. Ensures efficient technical transfer of API manufacturing processes to the commercial manufacturing site and transfer of appropriate analytical methodology to support registration; provides support for transfer from Merial development groups to toll manufacturer as required by Industrial Operations.

Major responsibilities:

Reporting to the Head of Pharmaceutical R&D, provides leadership and direction for Merial’s Active Pharmaceutical Ingredient (API) program. This includes Research and Development efforts to develop and register innovative APIs, including the process development, scale-up, and effective transition into the commercial manufacturing environment.
• Directs the activity and motivates a staff of scientists and support personnel to ensure timely achievement of R&D and project objectives towards effective development of API that address global business needs.
• Ensures appropriate planning, generation and analysis of data as a basis of chemical and biological documentation to support worldwide registration of API in accordance with GLP/GMP and other applicable regulatory requirements.
• Directs efforts to ensure appropriate and successful transfer of technology to commercial manufacturing sites worldwide, and provides support for in-line extensions and modifications.
• Facilitates appropriate interaction among Department and Division personnel on technical and project related matters. This includes interaction with personnel across R&D, as well as interaction across other Divisions, including Industrial Operations and Global Strategic Supply Chain. Effective interaction is also required with personnel in Shareholder Companies and external organizations including Contract Research Organizations and toll manufacturers.
• Ensures that functional excellence is maintained in support of project teams, product development, and product maintenance.
• Provides efficient management of staff (including recruitment, training, performance planning and review, promotion, motivation and safety) and operations (including equipment and budget).
• Maintains a knowledge of competitive developments that may impact the commercial viability of candidate products and recommends strategies to combat their effects.
• Ensures proactive action to secure and expand Merial intellectual property and provides input and guidance for the Merial Pharmaceutical Discovery effort regarding new active ingredients.
• Enhances recognition of functions and facilities as centers of excellence by encouraging appropriate technical and scientific publication and presentation to internal and external audiences, including appropriate industry, regulatory and standards committees.
• Is responsible for profit plan development and management of budgets for the departments and areas for which incumbent has responsibility.

 

Qualifications include:

 

• PhD (or equivalent) in Chemical Sciences or Pharmacy and with at least 10 years of relevant experience in pharmaceutical product development and management.

Knowledge and skills:
• Solid working knowledge of pharmaceutical product development including both API and Formulated Product development, as well as scale-up and process transfer.
• Strong management skills to allow building and reinforcement of effective functions capable of performing in a matrixed environment.
• Excellent interpersonal skills allowing effective interaction within functional areas, across other groups in R&D, within other Divisions of Merial, and externally with Shareholders, collaborators and regulators.

 

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