Senior Process Development Leader – API Synthesis

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Equal employment opportunity

Job summary

Ash Stevens, LLC, a division of Piramal Pharma Solutions, is seeking a Manager, Process Development to lead critical drug development projects at our Detroit and Riverview facilities. The role requires senior scientific leadership to plan, organize, and execute process development activities within cGMP constraints and client contracts.

You will collaborate with QA, QC, Safety, Engineering, and Operations, report progress to site leadership, and help assess new projects for feasibility and

Qualifications

• Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering as required.
• Ten+ years of experience in drug development and chemistry research with leadership experience.
• Experience building and managing research teams is a plus.

Responsibilities

• Assess new projects to identify best chemical routes and resources for process development.
• Organize department work to meet timelines, specs, and FDA requirements.
• Conduct literature searches and lab work to evaluate routes and propose optimal development solutions.
• Lead development of in-process methods to monitor chemical processes.
• Provide technical opinions to elaborates safe, economical CGMP-compliant processes.
• Work hands-on in lab or plant as required.
• Generate and revise process development documentation (BPRs, specs, deviation reports).
• Interact with QA, QC, Engineering, Safety, and Operations to align project objectives.

Skills

Team leadership

Organizational skills

Communication skills

Scientific discipline

Self-motivated

Project management

Education

Ph.D. in Organic Chemistry

Ph.D. in Medicinal Chemistry

Ph.D. in Chemical Engineering

10+ years experience in drug development

Job description

Ash Stevens, LLC, a division of Piramal Pharma Solutions, is seeking a Manager, Process Development to lead critical drug development projects at our Detroit and Riverview facilities. The role requires senior scientific leadership to plan, organize, and execute process development activities within cGMP constraints and client contracts.

You will collaborate with QA, QC, Safety, Engineering, and Operations, report progress to site leadership, and help assess new projects for feasibility and