Senior Director of Operations (Maintenance, Engineering, + Facilities)

Forma Life Sciences•Irvine, CA

18h•Onsite

About The Position

Forma is a next-generation Contract Development and Manufacturing Organization (CDMO) based in Irvine, California. The company was recently formed through the acquisition of the Irvine operations from BioDuro and is operating as a newly established, independent entity. As a result, Forma’s standalone online presence is still being built. We are a lean, entrepreneurial organization of approximately 60 employees focused on drug product development and manufacturing for pharmaceutical and biotechnology clients. Unlike large, highly layered organizations, Forma operates with a hands-on, execution-driven model. Our teams work closely across functions to solve complex technical and operational challenges, move quickly, and deliver consistently high-quality results. Employees at Forma are expected to take on meaningful responsibility, collaborate directly with colleagues and clients, and contribute to building scalable systems and processes as the company grows. This is an environment well suited to individuals who value autonomy, technical excellence, and the opportunity to help shape a growing organization. The Director of Manufacturing, Maintenance, Engineering, and Facilities is responsible for the overall management and oversight of the Manufacturing, Engineering, Maintenance, and Facilities departments. This role oversees operations related to the manufacturing of drug products and client manufacturing projects. The Director will be accountable for resource planning and allocation, budget management, financial performance, strategic growth, project management, quality and compliance, customer relations, and the supervision of manufacturing personnel. This position will also oversee the integration and coordination of engineering, maintenance, and facilities management within the manufacturing process to ensure seamless operations.

Requirements

BS or MS Degree in Pharmaceutics, Chemistry, Engineering, or other related fields.
A minimum of 12 years of pharmaceutical industry experience, with at least 7 years in team leadership roles.
Expertise in GMP (Good Manufacturing Practice) regulations.
Strong experience with solid oral dosage drugs required.

Responsibilities

Provide strategic, scientific, and managerial leadership for manufacturing, maintenance, engineering, and facilities operations.
Direct the Manufacturing Manager(s) to ensure all GMP manufacturing operations are executed safely, compliantly, and in accordance with approved batch records, production schedules, and quality requirements, while meeting on-time delivery commitments and operational performance targets.
Direct the Senior Maintenance and Engineering Manager to ensure all equipment and facilities, PMs, calibrations, repairs and maintenance activities are completed as per GMP and Safety compliance requirements and completed on time.
Provide leadership and oversight to Manufacturing Management to ensure efficient execution of clinical and commercial manufacturing operations, driving schedule adherence, operational excellence, continuous improvement, and compliance with cGMP and safety requirements.
Ensure all equipment and facilities are prepared and ready to execute scheduled client projects as per client timelines.
Collaborate with executive management to plan for the growth and expansion of the manufacturing, maintenance, engineering, and facilities business.
Responsible for the financial performance of the department, including revenue generation, profit margins, and meeting financial goals set for the manufacturing, maintenance, engineering, and facilities business.
Set project timelines, budgets, and resource requirements, ensuring these goals are met.
Hire, train, and supervise personnel across manufacturing, maintenance, engineering, and facilities teams.
Manage manufacturing, maintenance, engineering, and facilities activities, assign projects to appropriate teams, and provide directions to resolve complex technical issues.
Ensure cGMP compliance and maintain quality standards for all manufacturing activities.
Interact with clients to provide project status updates and resolve technical and manufacturing-related issues.
Establish and maintain productive working relationships with other departments, coordinating and communicating manufacturing, maintenance, engineering, and facilities-related activities that may impact other teams within the company.
Coordinate the transfer of formulation and process development activities to GMP manufacturing.
Stay informed about product and platform development trends in the pharmaceutical industry.
Represent the company to external audiences and clients, supporting business development efforts as the head of manufacturing, maintenance, engineering, and facilities.
Perform other duties as assigned.