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POSITION SUMMARY:
The (Senior) Principal Process Development Scientist will serve as a subject matter expert (SME) for the development of new processes for the synthesis of API or API candidates at both the Detroit and Riverview manufacturing facilities. The incumbent will help with 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 Ash Stevens, Inc. (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 Ash Stevens, LLC. leadership with technical input regarding the feasibility of the project. Prepare technical reports and participate in the bi-weekly meetings with Ash Stevens, Inc. 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 Ash Stevens’ 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 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.
- 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 or Medicinal Chemistry.
- 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.
Responsibilities
Carries assigned tasks under the supervision of a senior member of the group.Develop, conduct, and/or manage the process development of current and new synthetic/process pathways under minimal supervision.Maintain communications with clients and ensure their requirements are met.Manage the production of new APIs. Ensure that adequate supplies of process materials (raw materials, solvents, reagents, etc.) and operation equipment (hoses, reactors, glassware, etc.) are available for assigned tasks.Ensure that product shipments meet customer and regulatory (FDA, EPA, OSHA, etc.) requirements.Write progress reports and provide technical support in meetings regarding current API production and new API process development.Ensure that approved processes are carried out according to cGMP guidelines and are properly documented.Keep Quality Assurance and Quality Control departments updated in regard to project/client requirements and schedules. Participate in the development, training, and transfer of new processes into the plant. Maintain accurate inventories of materials.Prepare appropriate reports as needed for management and/or clients.Maintain notebooks for research and development and non-GMP activities. Complete and audit production and cleaning records. Complete logbooks and documentation (dispensing record, BPRs, cleaning records, deviation reports, etc.) related to production and cleaning is accordance with regulatory requirements.Generate and/or evaluate standard operating procedures as required.Provide technical support for chemical operators, engineering, quality control, etc.
Qualifications
To be qualified as a PD Associate, a candidate must have a Ph.D. in Chemistry, or Organic Chemistry and 0-3 years’ research experience or postdoctoral experience.Job Info
- Job Identification 90441119
- Job Category R & D
- Posting Date 07/07/2025, 10:34 PM
- Degree Level Post PHD or Higher
- Job Schedule Full time
- Locations Ash Stevens LLC, Riverview, MI, 48193, US
