Senior Director of Operations - Maintenance, Engineering, and Facilities

About Forma

Forma is a cutting-edge Contract Development and Manufacturing Organization (CDMO) headquartered in Irvine, California. It emerged as an independent company following the acquisition of the Irvine site from BioDuro. The company is relatively new and operates with a lean workforce of about 60 employees, focusing on pharmaceutical and biotechnology drug product development and manufacturing.

Unlike traditional large-scale companies, Forma emphasizes a flat organizational structure and a practical, action-oriented approach. This allows teams to work closely across departments, tackle complex technical and operational challenges, move quickly, and maintain high-quality results consistently. Employees at Forma are entrusted with significant responsibilities, encouraged to collaborate directly with clients and colleagues, and empowered to contribute to the growth of scalable systems and processes.

Role Summary

The Senior Director of Operations will oversee the Manufacturing, Maintenance, Engineering, and Facilities functions, ensuring smooth integration and execution of operations linked to drug product manufacturing and client projects. This leadership role involves managing resources, finances, compliance, quality, project timelines, and personnel supervision.

Key Responsibilities

• Lead strategically and scientifically across manufacturing, maintenance, engineering, and facility operations.
• Guide Manufacturing Managers to perform GMP-compliant drug manufacturing safely and according to batch records, production plans, and quality standards while meeting delivery schedules and performance benchmarks.
• Oversee Senior Maintenance and Engineering Managers to ensure timely completion of equipment maintenance, calibrations, preventive maintenance, and repairs in compliance with GMP and safety standards.
• Drive manufacturing operations execution with emphasis on schedule adherence, operational excellence, continuous improvement, and compliance.
• Prepare all equipment and facilities to meet client project timelines effectively.
• Collaborate with senior leadership to strategize for growth and expansion of the manufacturing, maintenance, engineering, and facilities departments.
• Manage departmental financial performance, including revenue, profits, and financial objectives.
• Establish and manage project budgets, timelines, and resource plans.
• Recruit, develop, and supervise a multidisciplinary team across manufacturing, maintenance, engineering, and facilities.
• Delegate projects appropriately and resolve complex technical and operational challenges.
• Maintain cGMP compliance and uphold quality standards in all manufacturing activities.
• Engage with clients to update project progress and address technical or manufacturing concerns.
• Foster effective collaboration with other company departments to synchronize activities impacting multiple teams.
• Coordinate transfer of formulation and process development to GMP manufacturing phases.
• Keep abreast of pharmaceutical product and platform development trends.
• Represent Forma externally, supporting business development and client relations for manufacturing and operations divisions.
• Perform additional tasks as needed; role responsibilities may evolve over time.

Qualifications

• Bachelor’s or Master’s degree in Pharmaceutics, Chemistry, Engineering, or a related discipline.
• At least 12 years of experience in the pharmaceutical industry, with a minimum of 7 years in leadership roles managing teams.
• In-depth knowledge of GMP regulatory requirements.
• Specific expertise in the manufacture of solid oral dosage forms.

Equal Opportunity and Accommodation

Forma is committed to diversity and is an Equal Opportunity and Affirmative Action Employer. Employment consideration is given without regard to legally protected characteristics. Reasonable accommodations are provided for applicants with disabilities or disabled veterans who require assistance during the hiring process.

Compensation & Benefits

• Competitive base salary range of $180,000 to $220,000 annually, dependent on experience and qualifications.
• Comprehensive health insurance coverage.
• Paid vacation and sick leave.
• Generous bonus program.
• 401(k) retirement savings plan.
• Engaging employee events fostering workplace culture.