Manager, Process Development

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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.

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Job Title

Job Description

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 peoples opinions. Participate in meetings with potential clients and brokers to provide input to ASIs 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.

job competencies:

• Able to direct and interact with team members.
• Excellent organizational and planning skills.
• Strong written verbal and interpersonal communication skills.
• Have the ability to develop perform evaluate and troubleshoot within a scientific discipline.
• Self-motivated creative and independent.
• Ability to manage projects covering a variety of chemical compounds.