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Sr. Manager Process Development buy in US, Free Classifieds Ads

Our client is currently seeking a (Senior) Manager, Process Development will serve as a member of the technical leadership for the development of new processes for the synthesis of API or API candidates at both the Michigan manufacturing facilities. The incumbent will help with the planning and organization of all activities in the Chemical Process Development department to ensure that timelines, specifications, cGMP requirements, and the other terms of contracts are fully respected. Provide technical expertise at the request of the Director/Senior Director and other departments and employees. Interact with the other departments of my clients. (Quality Assurance, Quality Control, Safety, Engineering, Operations, etc.) so that all resources required for developing and approving a process are in place. Periodically inform the client with the status of the project.?


Participate in potential new project assessments to provide to my clients leadership with technical input regarding the feasibility of the project. Prepare technical reports and participate in the bi-weekly meetings with my clients leadership. To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. ?Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices. ?Consistent support and practice of all my clients mission and values. ?Identify and protect the original technical information as part of the company property.?


KEY ACCOUNTABILITIES: ?Assess new projects with the department in order to identify the best chemical route and resources to be used in order to develop a process. ?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 by-products and impurities generated in different steps of a process and find the conditions to diminish/suppress or remove them. ?Direct the development of ?in-process methods? to monitor chemical processes. ?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. ?Work in the laboratory or plant (hands-on) as required. ?Generate, verify, approve, and revise BPRs, specifications, deviation reports, and development reports. ?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 in order 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 my clients 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. ?Actively participate in technical talks to find solutions to different problems and carefully consider other opinions and suggestions for future work.


EDUCATION/EXPERIENCE:

?Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.?

?Minimum ten (10) years? experience in research and chemical development of drugs and fine chemicals, with a proven track record of contribution in the field.

?Wide knowledge of classic and modern synthetic methods (excluding Chemical Engineers).?

?Up to five (5) of successful track record of building and managing research teams.

?Familiar with project management tools and best practices.?



 
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