Sr. Director, Novato Engineering and Facility Services (NEFS)
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Senior Director of Novato Engineering and Facility Services (NEFS) is a key leadership position at the Novato Site that will directly support product delivery, BioMarin objectives, and other programs executed at the Novato manufacturing site. Under the leadership of the Senior Director, the NEFS team enables the Make Assess Release of Drug Substance and Drug Product by ensuring that facilities, utilities, and equipment (FUE) are fit for purpose, aligned with production plan commitments, and compliant with cGMP expectations. The Senior Director will be responsible for directing and controlling the activities of the Novato site’s Utilities & Facilities Maintenance, Process Engineering, and Automation Engineering functions.
The Senior Director of NEFS reports to the VP of Novato Operations and is a member of the Novato Site Leadership Team and the network Senior Manufacturing Leadership Team.
Responsibilities include but are not limited to the following:
- Track and trend Novato Site FUE performance utilizing KPIs and link data to improvement initiatives which will maximize plant uptime in order to meet production plan commitments.
- Maintain support for building management systems (BMS) and other plant automation, including the design, implementation, and documentation of system changes. Interface with QA Validation group for GMP systems.
- Assist with troubleshooting complex mechanical or control system problems. Assure integrity of equipment operation as the result of troubleshooting or repair. Periodically review equipment or system alarms to identify adverse trends and potential failure points.
- Perform or coordinate analyses assessing utility capacity and optimization
- Maintain current in technology associated with utility systems, process equipment and control technology
- Support site production targets through ongoing support to Manufacturing via Utilities & Facilities Maintenance, Process Engineering, and Automation Engineering teams.
- Maintain engineering documentation for facilities, equipment, utilities and controls in a cGMP compliant state.
- Develop systems for FUE life cycle analysis and planning.
- Champion harmonization and alignment within global facility network.
- Recruit, direct, coach, and develop NEFS team and maintain team’s technical and interpersonal skills.
- Champion and sustain an environment of continuous improvement (CI) through active implementation of CI projects (Capex or Opex), GEPs and reliability practices, Right First Time principles, and Lean manufacturing methods.
- Provide project management leadership to ensure effective planning and time execution of all agreed projects.
- Effectively manage site capital projects portfolio.
- Lead change initiatives as requested and required by Site Leadership in support of the Site Strategic Objectives.
- Responsible for developing department long range plans, annual budgets, and monitoring/controlling budget performance.
- Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management for the immediate team.
The work product from the Senior Director of NEFS will directly support product delivery and other programs executed in the network, will be a major driver for FUE lifecycle management (LCM) strategies, and will highly impact site operations and network strategies.
- BS or MS in engineering discipline required
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
Required Experience and Abilities:
- Minimum 15 years of experience with the design, installation, startup, and servicing of process equipment, utility systems in the biotech industry.
- At least 12 years GMP/GCP compliant Biopharma operations experience required
- Extensive experience in building management systems (BMS), distributed control systems (DCS), mechanical operation of equipment, and process control and data acquisition systems are essential.
- Exceptional communication skills required, as this position will require interaction at all levels of the organization. Project management skills are key.
- Demonstrated ability to partner with other functional groups to achieve business objectives required
- Experience successfully leading transformational change
- Superior communication skills – oral, written and formal presentation skills with senior management, middle management and line staff
- Creative problem solving skills
- Comfortable and effective working indirectly through others
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.