Job Title:	Head of R&D
Market Sector:	Generics Company
Job Type:	Pre-Clinical R&D
Location:	India
Salary:	Competitive salary and benefits package with additional expatriate benefits negotiated as appropriate on an individual basis.
Reference:	5kjt2146
Consultant:	Keith Thrower
Background
Our client is a fast-growing, R&D-intensive and forward-looking chemicals manufacturer with a reputation for quality and innovation. In just over ten years, the company has grown from a single site company, supplying phase-transfer catalysts and other quaternary compounds, to a multi-site, global supplier of a diverse range of products, with turnover increasing from less than US$1 million in 1990 to almost US$30 million in 2004. The company is one of the leading bulk drug suppliers in India, and this activity represents about 20% of its business. Process R&D and contract manufacturing account for about another 40%, with the remaining 40% covering a wide range of speciality products and activities. Research is critical to the company, because it is the foundation of its broadly-based business. It has consistently invested almost 10% of its turnover into research. As a result, it has built up considerable R & D strengths, centered on the efforts of its scientific and technical personnel. All products produced currently have been developed in-house. The technologies used are not only cost effective, but also provide consistent and high purity quality products. R&D effort is also aimed at continuously upgrading existing manufacturing techniques, to improve processes, yield and quality A new, state-of-the-art R&D Centre has recently been opened with a cGMP pilot facility and the latest analytical instruments for R&D, as well as sophisticated pilot equipment. This investment is aimed to gain international recognition from reputed pharmaceutical companies around the world. The Centre has eight contract research and development units, and will be staffed by 200 R&D scientists. It will focus on contract research, new product development, kilo quantity production in the pilot plants, development of “high potency” molecules and preparation of drug master files. The facility will also undertake contract development work on the optimisation of the synthesis of APIs and the transfer of optimised chemistry to larger scale production as a preliminary step to contract manufacture. As a result of this expansion, the company is seeking to recruit a highly experienced scientist to lead the Research & Development Group working on synthetic route optimisation and contract manufacture.
The Job
The position will have the following major responsibilities: Lead and manage the Research & Development Group in accordance with the budget, development strategy and agreed timescales. Set policy for the development of products, including such issues as GMP (and GLP and GCP, when appropriate), as well as health, safety and environmental matters, and scientific standards and economics. Interact with staff at all levels within Manufacturing, Marketing, Technical Operations, Regulatory Affairs and QA areas. Interact especially closely with Manufacturing and Regulatory Affairs to ensure that support for marketed products and related regulatory compliance issues, eg CMC and Drug Master File issues, are covered. Lead and oversee those managing the transfer of product from Development into the Pilot Plant and into Manufacturing. Ensure that any Intellectual Property embodied in novel chemistry leading to new synthetic routes and/or processes, is protected on behalf of Dishman, the client or both. Provide analytical support as needed. Ensure that all SOPs are followed and regulatory requirements adhered to. Manage the balance between in-house and outsourced resource requirements ensuring that core competence is maintained internally. Be responsible for budgets and service levels of the department, including a detailed capital expenditure plan. Ensure the department has the right number of staff with appropriate skills and experience, deployed effectively to meet the development priorities.
Candidate Requirements
The successful candidate will meet the following criteria: Essential: A degree or equivalent in Chemistry, and a higher degree in Synthetic Organic Chemistry. A proven track record of synthetic route optimisation and process development, with respect to organic molecules developed on a small scale and produced on a large scale. Broad experience of a chemical development and manufacturing environment, within a strong regulatory, QA/QC and cGMP culture. Several years' management experience, with proven effective people management skills, leadership qualities, and the ability to manage and work within a multicultural environment. Desirable: Demonstrated involvement in the validation of chemical processes for regulatory purposes. Personal Qualities: Proactive, decisive and strongly focused on ensuring that projects are completed successfully, on time and to the standard expected. Good oral and written communication skills, including fluency in English. Able to deal with outside agencies and customers at all levels. Willingness to travel internationally.