Director 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

LOCATION

Detroit, Michigan (Full relocation support provided)

POSITION SUMMARY

The Director, Process Development serves as a key member of the technical leadership team, responsible for the development and commercialization of chemical processes for the synthesis of APIs and API intermediates. This role provides strategic and technical oversight of process development activities, ensuring projects are delivered on time, within scope, and in compliance with cGMP, regulatory, safety, and quality requirements.

The successful candidate will work cross-functionally with Quality, Manufacturing, Engineering, Analytical Development, Regulatory, and other technical functions to ensure all resources, processes, and deliverables are aligned to project objectives. The role also supports client interactions, technical evaluations of new business opportunities, and site leadership initiatives.

KEY RESPONSIBIILITIES

• 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.

EDUCATION & EXPERIENCE

• 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.

SKILLS & KNOWLEDGE

• Advanced knowledge of synthetic organic chemistry and chemical process development.
• Strong understanding of API manufacturing, pharmaceutical development, and cGMP requirements.
• Experience working in laboratory, pilot plant, and commercial manufacturing environments.
• Knowledge of pharmaceutical CMC development, analytical chemistry, and regulatory requirements.
• Proven project management and cross-functional leadership capabilities.
• Strong problem-solving, communication, and stakeholder management skills.
• Demonstrated ability to manage resources, priorities, and multiple projects simultaneously.
• Thorough understanding of safety, environmental, and regulatory compliance requirements within pharmaceutical or chemical manufacturing environments.

REGUALTORY & COMPLIANCE EXPECTATIONS

• Maintain compliance with all applicable cGMP, FDA, OSHA, EPA, environmental, health, and safety requirements.
• Support a culture of quality, safety, integrity, and continuous improvement.
• Ensure all technical activities and documentation meet internal and external regulatory standards.