Manager, Process Development

Division

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

We provide a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services such as development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider and experience with various technologies enables us to serve Innovator and Generic companies worldwide.

Manager, Process Development

The 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 Detroit and Riverview manufacturing facilities for Ash Stevens, LLC, a division of Piramal Pharma Solutions. 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.

This position will also provide technical expertise at the request of the Head of Process Development and other departments and employees. You will collaborate and interact with the other departments of Ash Stevens (Quality Assurance, Quality Control, Safety, Engineering, Operations, etc.) so that all resources required for developing and approving a process are in place. Periodically this role will inform the client with the status of the project.

This role will actively participate in potential new project assessments to provide Site Leadership with technical input regarding the feasibility of the project, and will also prepare technical reports and participate in the site management meetings/team.

• 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…