Director, Process Development: Lead Innovative API Routes

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 140,000 - 210,000; Full time

Job summary

Piramal Pharma Solutions Riverview is seeking a Director of Process Development to lead the chemical process development for API synthesis at the Riverview facility. You will coordinate with QA, QC, Safety, Engineering and Operations to ensure contractual and cGMP requirements are met while providing regular client updates.

The role involves directing staff, coordinating with senior leaders, and ensuring safe and efficient lab and plant operations, with a focus on scalable manufacturing

Qualifications

• Proven skills in project management methodology and application.
• Advanced knowledge of synthetic organic and process chemistry.
• Strong knowledge of pilot plant and kilo lab production under cGMP.
• Understanding of CMC, regulatory affairs is a strong asset.

Responsibilities

• Assess new projects to identify optimal chemical routes and resources.
• Lead department meetings and coordinate with Process Development managers.
• Ensure timeliness, specs, and FDA compliance across projects.
• Develop process R&D plans to enable on-time delivery of objectives.
• Provide technical opinions for safe, economical manufacturing processes.

Skills

Project management

Organic chemistry

Process development

Leadership

cGMP understanding

Education

Master or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering

Job description

Piramal Pharma Solutions Riverview is seeking a Director of Process Development to lead the chemical process development for API synthesis at the Riverview facility. You will coordinate with QA, QC, Safety, Engineering and Operations to ensure contractual and cGMP requirements are met while providing regular client updates.

The role involves directing staff, coordinating with senior leaders, and ensuring safe and efficient lab and plant operations, with a focus on scalable manufacturing