Lead Process Development for APIs & HPAPIs

Piramal Pharma Solutions; Riverview (MI); On-site; USD 150,000 - 230,000; Full time

Job summary

Piramal Pharma Solutions in Michigan seeks a Manager, Process Development to lead the technical development of robust, scalable routes for API and HPAPI synthesis, ensuring cGMP compliance for clinical trials, toxicology studies, and commercial APIs. You will coordinate cross‑functional teams across QA, QC, Safety, Engineering, and Operations to meet timelines and contract terms.

The role requires hands‑on lab and plant work, oversight of process development activities, and preparation of

Qualifications

• PhD in organic/medicinal chemistry or chemical engineering.
• 5–10 years in drug development and chemical process development.
• Extensive knowledge of cGMP and HPAPIs.
• Experience with DOEs, process characterization, and NMR.
• Ability to manage multiple projects and work independently.
• Excellent written and oral communication; client interaction.

Responsibilities

• Assess new projects to identify the best chemical route and resources.
• Organize department work to meet timelines and FDA requirements.
• Conduct literature searches and lab work to identify routes and limitations.
• Develop in-process methods to monitor chemical processes.
• Provide technical opinions to elaborate safe, economical manufacturing processes.
• Work hands-on in the lab or plant as required.
• Generate, verify, and revise development reports and specifications.
• Execute GMP lab-scale processes for APIs including HPAPIs.
• Participate in technical talks to find solutions and consider feedback.
• Represent Process Chemistry on cross-functional teams with QA, QC, and Tech Transfer.
• Promote teamwork and open communication within the department.
• Participate in client meetings to discuss technical aspects of opportunities.
• Collaborate with clients for efficient transfer of information.

Skills

Project management

Leadership

Communication

Process development

Education

PhD in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering

Job description

Piramal Pharma Solutions in Michigan seeks a Manager, Process Development to lead the technical development of robust, scalable routes for API and HPAPI synthesis, ensuring cGMP compliance for clinical trials, toxicology studies, and commercial APIs. You will coordinate cross‑functional teams across QA, QC, Safety, Engineering, and Operations to meet timelines and contract terms.

The role requires hands‑on lab and plant work, oversight of process development activities, and preparation of