Director, API Process Development & Strategy

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 170,000 - 250,000; Full time

Job summary

Piramal Pharma Solutions Riverview is seeking a Director of Process Development to lead advanced drug process development efforts for API synthesis. You will plan activities, ensure cGMP compliance, manage timelines, and coordinate with QA, QC, Safety, Engineering, and Operations to secure resources.

This role requires a Master’s or PhD in organic/medicinal chemistry or chemical engineering, plus at least five years of leadership in drug development and a track record of delivering projects on

Qualifications

• Master or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
• Minimum five years’ experience in research and chemical development of drugs and fine chemicals.
• Wide knowledge of classic and modern synthetic methods.
• Up to five years of successful track record of building and managing research teams.
• Familiar with project management tools and best practices.

Responsibilities

• Assess new projects to identify the best chemical route and resources.
• Allocate project resources (lab space, equipment and staff).
• Provide leadership in regular departmental meetings and project leadership roles.
• Ensure timeliness, specifications and FDA requirements are respected.
• Develop process research & development project plans to ensure on-time delivery.
• Coordinate with Analytical Development to monitor in-process methods.
• Prepare technical reports and participate in site management meetings.

Skills

Project management

Process chemistry

Leadership

Regulatory affairs knowledge

Education

Master's or PhD in Organic Chemistry/Medicinal Chemistry/Chemical Engineering

Job description

Piramal Pharma Solutions Riverview is seeking a Director of Process Development to lead advanced drug process development efforts for API synthesis. You will plan activities, ensure cGMP compliance, manage timelines, and coordinate with QA, QC, Safety, Engineering, and Operations to secure resources.

This role requires a Master’s or PhD in organic/medicinal chemistry or chemical engineering, plus at least five years of leadership in drug development and a track record of delivering projects on