DIRECTOR – FORMULATIONS DEVELOPMENT MUMBAI FROM WWW.EXECEX.COM

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Position Specification


THE POSITION

Title: DIRECTOR – FORMULATIONS DEVELOPMENT

Reports to: SENIOR DIRECTOR – INDUSTRIAL AFFIARS (INDIA) & GLOBAL FORMULATIONS TEAM

Duties: The broad outline of duties include:

- Drive formulations development including line extensions, developing products in house as well as through other parties
- Identify local partners for Formulations Development/Process Chemistry (defining commercial route for API)
- Oversee Analytical support; Quality Assurance and Documentation. Ensure that filings are made to the timelines agreed in plans and meet Sanofi-Aventis quality standards
- Ensure the maintenance of high standards of safety and security
- Planning & management of new product launches
- Lead different Formulation development teams like Process Development, Packaging Development and International Regulatory Affairs (IRA) etc.
- Co-ordinate with regulatory department for the compilation of registration dossiers
- Scale up developed products to commercial scale
- Develop bio-equivalent, patentable/patent non-infringing generic products and extensions
- Transfer lab scale technology to the plant through optimization and validation of process on the pilot/production scale batches.

Challenges:

The candidate will face the following challenges in the position:

- Maintain business continuity during the gradual transition of projects to India
- Managing timelines and meet scheduled milestones
- Lowering the cost of pharmaceutical development and creating operations that serve as a strategic advantage to company globally
- Maintaining high standards of safety, security and communication within global operations
- Maintaining awareness of outsourcing and off shoring initiatives in the Indian subcontinent) and ensuring appropriate alignment with Sanofi-Aventis global initiatives
- Maintaining awareness of industry trends in outsourcing and Third Party Manufacturing (TPM) capabilities in lower- cost geographies (expecially India and China)
- Manage multiple projects simultaneously (e.g., 8-12 at a given time)
- Work successfully within a global matrix environment
- Candidate must possess scalable skill sets – lead scientific and technical initiatives

THE ORGANIZATION

Location: Mumbai

Employees: The organization will be scaled up to reach about 40-50 formulations research professionals by the end of 2006

Description:

The Position – This is a Director level position and the candidate will be responsible for the Formulations Development/Research initiative for Sanofi Aventis, based in India

The candidate will actively initiate and work on formulations research and development, scale-up and registration activities

The position (and operation) will be independent from other Sanofi Aventis operations in India (except for local HR practices). There will be a dotted line to the Senior Director-Industrial Affairs of Sanofi Aventis India

Key Deliverables include: successful global regulatory approvals of new products and successful transfer of cost-efficient processes into commercial manufacturing environments, develop new product extensions and documentation and quality assurance requirements. Managing to timelines and meeting scheduled milestones will be critical

This position will oversee “outsourced” functions such as Formulations development & research, which will include related Analytical support; Quality Assurance and Documentation


THE PERSON

Experience: Minimum 10-15 years of experience within the Pharmaceutical Industry.

Education: Must be a PhD in Pharmacy

Background: Must have been a General Manager/Senior Manager – Formulations Research within a pharmaceutical company with globally benchmarked processes. Must have demonstrated a clear ability in formulations development/research and processes

Experience:

- 15 years experience within the Pharmaceutical Industry, the majority of which has been in a Pharmaceutical Sciences discipline
- 5 years experience of management at a senior level in the Pharmaceutical Industry
- Prior experience in the pharmaceutical development and successful regulatory approval of one or more new products
- Experience in building or growing organizations would also be a plus.
- Candidate must possess scalable skill sets – lead scientific and technical initiatives

Preferable
- Experience running and expanding pharmaceutical development operations in India; with a proven track record of lowering the cost of product development
- Demonstrated expertise in transitioning portfolio of projects and leveraging India’s low cost advantage and research pool

Technical Competencies

- A good understanding of modern pharmaceutical technology
- A good understanding of pharmaceutical development
- Broad understanding of the global regulatory requirements for registration of new products particularly as pertaining to the CMC section
- Keen awareness of Intellectual property and the ability to ensure its protection in the Indian environment
- A good understanding of GMP/GLP
- Very familiar with Quality and US/EU regulatory guidelines
- Ability to manage multiple projects simultaneously
- Ability to work successfully within a global matrix environment
- Ability to make timely, quality decisions
- Financial awareness – ability to understand and manage budgets

CTC: 100,000+ US $
Should you have any questions or need our assistance, please feel free to contact me at shalaka.pradhan@execex.com