Regional Head of API R&D
- Assess new projects with the department to identify the best chemical route and resources to be used in order to develop a process that is scalable to meet client needs.
- Organize work within the department to ensure that timeliness, specifications, and FDA requirements are respected and correlate with most effective and economic use of the resources.
- Conduct literature searches and laboratory work to quickly identify the potential and limitations of different routes and propose the optimal solution for development.
- Contribute to the efforts to identify, characterize, and synthesize the by-products and impurities generated in different steps of a process and find the conditions to diminish/suppress or remove them.
- Provide technical opinions and recommendations to the members of the Process Development Department in order to elaborate chemical manufacturing processes that are safe, economical, and in compliance with cGMP requirements.
- Verify, approve, and revise Batch Production Records (BPRs), specifications, deviation reports, and development reports.
- Present technical reports to Senior Vice President & Regional API Head, NA, as well as Regional and Site Management, as appropriate. Actively participate in technical talks to find solutions to different problems and carefully consider opinions and suggestions for future work.
- Periodically interact with QA, QC, Engineering, Safety, and Operations departments to ensure all aspects of a project under development are being taken into consideration.
- Identify and protect the original technical information as part of the company property.
- Promote a friendly and cooperative environment for all members of the department to facilitate open communication. Strongly encourage teamwork and carefully consider and analyze other people’s opinions. Participate in meetings with potential clients and brokers to provide input to ASI’s Senior Management about technical aspects of potential business opportunities for the company. Interact with clients in a positive and constructive manner.
- Work with clients for an efficient transfer and implementation of the technological analytical information.
- Provide direction, support, and prioritization for process / facility improvements.
- Formulate succession plan for department and ensure proper development.
- Ensure regular communication meetings occur with department staff.
- Direct department activities to meet Production plan, including yield and throughput.
- Ensure Corrective Actions are completed in a timely manner.
- Continuously identify and address gaps in the department’s technical skills and technologies.
- PhD. in Organic Chemistry or Medicinal Chemistry
- Minimum 10-15 years’ experience in research and chemical development of drugs substances and fine chemicals, with a proven track record of contribution in the field.
- 8+ years of successful track record in building and managing process development teams.
- Significant process chemistry and cGMP experience at a pharmaceutical or API manufacturing company, preferably within a leadership position.
- Wide knowledge of classic and modern synthetic methods
- Experience with project management tools and best practices.
- Experience within a High Potent API environment