Director, Process Development

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Riverviewtime type:
Full time posted on:
Posted Todayjob requisition :
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* * Piramal Pharma Solutions 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.

This enables us to offer 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 like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit :(Use the "Apply for this Job" box below). Title Director, Process Development

Job Description The Director, 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 Piramal Pharma Solutions’ Riverview manufacturing facility. The incumbent will help with the planning and organization of some activities in the Chemical Process Development department to ensure that timelines, specifications, cGMP requirements, and the other terms of contracts are fully respected.

You will collaborate and interact with the other departments of PPS-Riverview (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 may participate in potential new project assessments to provide Site Leadership with technical input regarding the feasibility of the project and may also prepare technical reports and participate in the site management meetings/team.
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* Key Accountabilities:

*** May be asked to 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.
* Collaborate with Sr. Director & Regional API R&D Lead in allocating project resources (lab space, equipment and staff)
* Provide leadership to staff in regular departmental meetings, regular meetings with Managers of Process Development, and R+D project leadership roles
* Organize work within Process Development to ensure that timeliness, specifications, and FDA requirements are respected and correlate with most effective and economic use of the resources.
* Develops process research & development project plans in collaboration with the Process Development managers and other departments to ensure OTIF delivery of overall project objectives
* Ensure safe and clean lab operations
* 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.
* Participate in regular departmental meetings with direct reports.
* Working with Analytical Development, 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.
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