Senior Director, API Process Development

i‑Pharm Consulting; Detroit (MI); On-site; USD 150,000 - 210,000; Full time

Job summary

i‑Pharm Consulting, located in Detroit with full relocation support, seeks a Director of Process Development to lead API process development and tech transfer. You will guide cross-functional teams across Quality, Manufacturing, Engineering, and Regulatory to deliver compliant, scalable manufacturing processes.

The role requires advanced synthetic chemistry expertise, 5+ years in pharma process development, and strong project leadership to drive product commercialization and client engagements.

Qualifications

• Master's degree or Ph.D. in Organic Chemistry, Medicinal Chemistry, Chemical Engineering, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical, API, fine chemical, or specialty chemical process development.
• Demonstrated expertise in synthetic organic chemistry and process development for commercial manufacturing applications.
• Proven experience leading, developing, and managing technical teams.
• Strong understanding of project management principles, tools, and best practices.
• Experience supporting 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, collaboration, and professional development.
• Ensure project timelines, specifications, regulatory requirements, and client expectations are achieved.
• Develop project plans and coordinate cross-functional activities to ensure successful project execution and on-time delivery.
• Oversee laboratory operations, ensuring safe, compliant, and efficient working practices.
• Conduct and direct literature reviews, route scouting, and process optimization activities.
• Drive impurity identification, characterization, and control strategies to support 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 laboratory, pilot plant, and manufacturing operations as needed during process development and scale-up activities.
• Review and approve technical documentation, including development reports, batch records, specifications, investigations, and deviations.
• Participate in technical reviews and problem-solving discussions to identify and implement process improvements.
• Work closely with Manufacturing, Quality Assurance, Quality Control, Analytical Development, Tech Transfer, Engineering, and EHS teams to ensure successful project progression.
• Support technology transfer activities from development through commercial manufacturing.
• Participate in client meetings, technical discussions, and business development activities, providing subject matter expertise and project updates.
• Foster a collaborative, team-oriented environment that promotes open communication and continuous improvement.
• Protect and maintain confidentiality of proprietary technical and intellectual property information.

Skills

Synthetic chemistry

API manufacturing

cGMP knowledge

Project management

Cross-functional leadership

Regulatory compliance

Safety & EHS

Stakeholder management

Education

Masters/PhD in Chemistry/Engineering

Job description

i‑Pharm Consulting, located in Detroit with full relocation support, seeks a Director of Process Development to lead API process development and tech transfer. You will guide cross-functional teams across Quality, Manufacturing, Engineering, and Regulatory to deliver compliant, scalable manufacturing processes.

The role requires advanced synthetic chemistry expertise, 5+ years in pharma process development, and strong project leadership to drive product commercialization and client engagements.