Senior Process Development Leader - API Manufacturing

i‑Pharm Consulting; Detroit (MI); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

i‑Pharm Consulting in Detroit seeks a Manager of Process Development to lead the design, development, and commercialization of APIs and intermediates, ensuring projects meet timelines, scope, and cGMP requirements.

This role collaborates with Quality, Manufacturing, Engineering, Analytical Development, Regulatory, and others, while supporting client opportunities and technology transfer across sites.

You will mentor teams, optimize processes, and drive safety and continuous improvement.

Qualifications

• Master's degree or Ph.D. in Organic Chemistry, Medicinal Chemistry, Chemical Engineering, or a related discipline.
• Minimum of 5 years of experience in pharmaceutical, API, fine chemical, or specialty chemical process development.
• Proven leadership of technical teams and project management experience.
• Strong understanding of process scale-up, technology transfer, and manufacturing operations.

Responsibilities

• Provide technical and operational leadership for process development programs supporting API and chemical manufacturing projects.
• Assess new project opportunities and determine optimal synthetic routes, development strategies, and required resources.
• Partner with senior leadership to allocate laboratory space, equipment, and personnel across multiple projects.
• Lead and mentor Process Development teams, fostering technical excellence and collaboration.
• Ensure project timelines, specifications, regulatory requirements, and client expectations are achieved.
• Develop project plans and coordinate cross-functional activities to ensure successful execution and on-time delivery.
• Oversee laboratory operations, ensuring safe, compliant, and efficient practices.
• Drive impurity identification, characterization, and control strategies for robust manufacturing processes.
• Collaborate with Analytical Development to establish in-process controls and analytical methods.
• Provide technical guidance on scalable, safe, cost-effective, and cGMP-compliant manufacturing processes.
• Support lab, pilot plant, and manufacturing operations during process development and scale-up.
• Review and approve technical documentation including reports, batch records, specs, investigations, and deviations.
• Participate in technical reviews and problem-solving discussions to implement process improvements.
• Work with Manufacturing, QA, QC, Analytical Development, Tech Transfer, Engineering, and EHS to progress projects.
• Support technology transfer from development to commercial manufacturing.
• Participate in client meetings and business development activities providing SME updates.
• Foster a collaborative environment promoting open communication and continuous improvement.

Skills

Synthetic organic chemistry

Process development

Project management

Cross-functional leadership

cGMP compliance

Scale-up & tech transfer

Education

Master's degree or PhD in Organic Chemistry / related field

Job description

i‑Pharm Consulting in Detroit seeks a Manager of Process Development to lead the design, development, and commercialization of APIs and intermediates, ensuring projects meet timelines, scope, and cGMP requirements.

This role collaborates with Quality, Manufacturing, Engineering, Analytical Development, Regulatory, and others, while supporting client opportunities and technology transfer across sites.

You will mentor teams, optimize processes, and drive safety and continuous improvement.