Senior Manager, Facilities and Engineering

Position Summary

The US Facilities & Engineering Team in Santa Monica is seeking a highly motivated individual with FDA regulation & current Good Manufacturing Practice (cGMP) knowledge for the role of Manager/ Sr. Manager of Facilities & Engineering, depending on experience to work in an exciting new area of cell therapy at Neogene Therapeutics. This individual must have extensive experience in GMP Manufacturing, Laboratory, Facility/Utility, and site services equipment. This role reports directly to the US Director of Facilities & Engineering. The individual for this position must possess strong collaborative capabilities as well as technical acumen and be comfortable managing the planning and implementation of capital and revenue projects ensuring that projects are delivered on time, to specification and on budget such that expected benefits are delivered to the business within a fast-paced and dynamic environment. This individual will blend proactive, forward-thinking, and risk-based approaches and provide fit for purpose solutions.

The Manager/ Sr. Manager of Facilities & Engineering is responsible for completing tasks which support the day-to-day operations and deliverables to the business, including design, development, implementation, and analysis of technical products and systems. This role will also perform equipment engineering design evaluations and maintenance activities.

Essential Functions and Responsibilities (include but not limited to):

• Manages day to day Facility and Engineering activities of Neogene's existing manufacturing facilities and laboratories at Santa Monica facilities.
• Aid in development, implementation, update and maintenance of a fit for purpose Asset Lifecycle Management System for all non-GMP and GMP assets.
• Aid in development, implementation, update and maintenance of a fit for purpose Calibration and Maintenance Program for all non-GMP and GMP Assets.
• Responsible for selection of vendors, execution of work orders by vendors and acting as a primary point of contact for facility maintenance services at the Santa Monica facility locations. Lead and manage capital project activities for clinical manufacturing including equipment procurement, equipment installation and qualification, facility qualification and technology transfer. Ensure that projects are delivered on time, to specification and on-budget.
• Take full ownership of all aspects of the project through entire lifecycle including Health and Safety, Quality Assurance / Control, Financial Budget, Cash-Flow, Procurement, Construction, Commissioning and Vendor Relationships
• Ensure projects are handed over to "customers" (Operations, Quality, Laboratory, etc) effectively and efficiently.
• Complete post CAPEX project appraisals to ensure lessons learned are applied and shared appropriately.
• Gather and compile requirements from various ownership functions to generate clear user requirement specifications for new assets as needed.
• Lead the installation, qualification (DQ, IQ, OQ, PQ) and commissioning of the equipment or facility, including leadership of Factory Acceptance Testing (FAT) at Original Equipment Manufacturers (OEM) and leadership of Site Acceptance Testing (SAT).
• Responsible for developing Preventative Maintenance (PM) procedure for all newly acquired equipment.
• Responsible for adherence to all relevant Health, Safety & Environmental guidelines throughout the lifecycle of projects and ensuring that project implementation and equipment usage meets all required regulations and cGMP.
• Complete analysis of potential suppliers and quantitatively select best option for the business and support equipment purchase negotiations.
• Develop facility layouts and other site drawings to identify material, waste and personnel flow.
• Support Operations teams in optimizing performance of the equipment troubleshooting, diagnostics, and issue resolution.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Provides guidance and leadership to engineering team regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Provide timely verbal and written updates to stakeholders & leadership.
• Other duties and projects as assigned to meet business needs.

Supervisory Responsibilities

• This position may hire, lead, develop & manage individuals from entry level to junior level experience.
• Responsible for managing contractors as part of the capital projects.

Required Skills/Abilities

• Possesses a strong technical knowledge and application of concepts, practices, and procedures.
• Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions.
• Proficient in the use of Computer-Aided Design (CAD) to update facilities, utilities, P&ID schematics, equipment, and tooling drawings.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
• Has demonstrated competency with financial systems and in fiscal control.
• Formal Project Management training (preferred)
• Clear understanding of GMP/GLP principles, concepts, practices, and standards.
• Organization skills for day-to-day activities and excellent communication and interpersonal skills.
• A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems.
• Ability to drive safety, quality, functional, technical, and operational excellence.
• Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
• Ability to make timely decisions and knowing when to escalate and when to delegate.

Education and Experience

• A bachelor's degree in engineering, or equivalent technical experience plus demonstrated competence, with a desired 8+ years of significant engineering and/or operational experience. A post-graduate education / degree is desired and may contribute towards the desired years of experience.
• Has a career history marked by a consistent series of technical contributions and accomplishments as it relates to facility, utility, and equipment. Significant contribution to product or process development or improvement through creative application of technical effort will equally be recognized.
• At least 5 years of pharmaceutical or biotech industry experience in increasing levels of responsibility and operational excellence or Lean manufacturing principles
• Minimum of 3+ years of people management experience

The anticipated salary range for candidates who will work in Santa Monica, CA is $ 145,000 to $171,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

Note: At this time, Neogene is not sponsoring VISAs

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is 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.