Senior API/HPAPI Process Development Lead

Piramal Pharma Solutions; Riverview (MI); On-site; USD 150,000 - 190,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Manager, Process Development to lead the development of new processes for API and HPAPI synthesis under GLP and cGMP. You will plan, organize, and manage activities to ensure timely, compliant development, reporting to the Head of Process Development and interfacing with QA, QC, Safety, Engineering, and Tech Transfer.

Strong regulatory, DOE and PD expertise are essential.

Qualifications

• Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
• Five to ten years of experience in research and chemical development of drugs and fine chemicals.
• Knowledge of cGMP and regulatory requirements for API development.
• Technical experience in handling High Potent APIs (OEL < 1 µg/m3).
• DOE and statistical analysis for process parameter design.
• Strong communication and project management skills.

Responsibilities

• Oversee API and HPAPI process development and lab-scale manufacturing.
• Ensure compliance with FDA, EPA, OSHA and cGMP requirements.
• Plan and organize activities in the Chemical Process Development department.
• Lead multiple projects and manage client communications.
• Develop robust, scalable routes for drug substances.
• Prepare technical reports and participate in site management meetings.
• Collaborate with QA, QC, Safety, Engineering and Tech Transfer across departments.

Job description

Piramal Pharma Solutions is seeking a Manager, Process Development to lead the development of new processes for API and HPAPI synthesis under GLP and cGMP. You will plan, organize, and manage activities to ensure timely, compliant development, reporting to the Head of Process Development and interfacing with QA, QC, Safety, Engineering, and Tech Transfer.

Strong regulatory, DOE and PD expertise are essential.