Senior Manager, Facilities
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.
The Role:
The Senior Manager Facilities (Sr. Mgr. Facilities) position will report directly to the Director of Facilities & Engineering BC-PITT and have overall responsibility for ensuring reliable, economical, and safe operation of facility services, utilities, and systems supporting business operations in compliance with applicable regulatory requirements and compliance. This role is responsible for ensuring the best maintenance and facilities operation practices for overall facilities’ needs, GMP and non GMP areas. Specifically supervising and executing the preventative maintenance, metrology, repairs, and installation for building utilities, HVAC, building control systems, water & steam systems, process equipment, determining and scheduling repairs or small renovation projects, and coordinating safety inspections. The Sr. Mgr. Facilities will propose and oversee budgets and timelines of the overall maintenance operations as well as for maintenance capital projects. Specifically, to provides strategic guidance in the development of Business Processes and Systems used to support Capital Project activity within BC-PITT, and will assure compliance of all Engineering, Asset Management, Capital, and Facilities related systems. Accountable for overseeing and directing efforts to define and implement the Asset Management program to support commercial readiness and operations, quality, and regulatory compliance.
Here’s What You’ll Do:
- Responsible for the execution and following of the site Preventive Maintenance and Calibration Programs.
- Drive Reliability and Continuous Improvement Projects for Facilities, Maintenance and Utilities
- Manage facility personnel and contractors for metrology/calibration, preventive maintenance, repair work and assist with checking installation and servicing building equipment and other maintenance functions.
- Ensure that the facility is fully operational with all utilities functioning properly, and in compliance with federal, state and those having jurisdiction regulatory bodies.
- Oversee Security Program
- Maintain ongoing communication with contractors, external and internal clients, and team members.
- Work with, and provide support to the Global Project Manager, Operations, Validation, IT-OT, QA/QC, Supply Chain, and MSAT.
- Maintain all department GMP systems in a Qualified state. Ensure Quality Commitments (CAPAs, Deviations, Change Controls) for the department are met on time.
- Plan organizational and technical strategies impacting budget, staffing, goals, and culture.
- Assist in departmental planning to ensure appropriate staff structure and resourcing to support services as required.
- Recruit, train, and guide resources to improve total performance and productivity. Establish training program and performance goals for the department.
- Provide oversight and direction to implement a life cycle Asset Management program at BC-PITT. This includes defining the department Vision and Roadmap, providing guidance to Site teams, setting expectations, establishing and monitoring metrics, interfacing with numerous groups and communicating the Vision to key Stakeholders across the Organization.
- Assist in the development and execution of the Capital Budget. This includes overseeing key capital projects to assure they are approved, executed on time, within budget, and deliver desired performance and scope.
- Assist in establishing a strategic guidance in development of Long-Term Capital Planning.
- Assist in the execution and continued development of the Capital Project Management Process within the organization. This includes collaboration with other departments to ensure best practices are identified and shared across the site network, implementing Engineering Design guidelines as appropriate and contributing to optimization of the RFP, DQ, Commissioning, and ETOP Processes.
- Providing support for the ongoing development of our Sites and facilities through development of Site Master Plans. This includes assessing facility designs with EHS, Regulatory and Operational requirements and promoting the use of innovative designs that provide improved performance. This also includes defining and optimizing processes utilized in the Development of Site Master Plans and promoting standardization across the Site where appropriate.
Requirements:
Qualifications:
- Bachelor’s Degree in STEM preferred and a minimum of 7+ years of experience in Metrology/Instrumentation, Facility maintenance, Engineering, Project Engineering, Maintenance, or Reliability Organizations in GMP environment.
- Track record of successful facilities management leadership experience as demonstrated by articulated results and accomplishments.
- Strong technical knowledge of the following: calibration, metrology, mechanical, electrical, plumbing, HVAC, safety systems, and maintenance systems (CMMS, CCMS)
- Knowledge and application of reliability methodologies and tools (e.g. Root Cause Analysis, FMEA, Structured problem solving, Lean and Six Sigma) is preferred.
- Demonstrated business and financial acumen with a strong P&L understanding. Strong project management and organizational skills.
- Working knowledge of cGMP aseptic operations, quality systems and cGMP principles.
- Solid knowledge of business and understanding of manufacturing processes to support manufacturing and clinical operations.
- Experience with maintenance and operation of facilities and manufacturing equipment in an active manufacturing environment.
- Must be self-motivated and able to quickly ramp up on the understanding of existing plant processes.
- Demonstrated diagnostic and problem-solving skills in a team environment.
- Able to communicate clearly and effectively with shop personnel, vendors, OEM suppliers, and all levels of company personnel.
- Ability to develop and deliver a clear and concise presentation.
- Relevant IT skills - able to work with CMMS, Visio, Microsoft Project and Excel, Security Systems.
Competencies:
- Experience with sustainability and energy programs for efficient operation of facilities and equipment.
- Ability to effectively interface with peer group in the company and team members demonstrating outstanding interpersonal skills, ability to deal with ambiguity and work collaboratively to achieve company goals.
- Ability to work autonomously in an entrepreneurial, fast paced environment with strong business acumen.
- Collaborative approach and ability to deal with ambiguity.
- Application of current Good Manufacturing Practices (cGMPs), Good Maintenance Practices and knowledge of applicable CFR regulatory requirements.
- Organizational competencies and project management skills to keep projects, processes, and maintenance team on track.
- Ability to think strategically and tactically (detail-oriented).
- Flexible and able to adapt to company growth and evolving responsibilities.
- Excellent written and oral communication and presentation skills with the ability to speak and communicate effectively with both senior management and front-line staff personnel.
- Meeting management/facilitation skills/teamwork.
- Does due diligence to complete projects within specified timeframes and/or fulfill commitments.
- Desire to learn and develop career within organization.
Supervisory Responsibility:
- This position requires a professional who will be expected to perform tasks autonomously at times; minimum supervision required on day-to-day activities and accomplished tasks.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles either currently or in the future:
- Facilities/Maintenance Technicians
- Metrology/Calibration Technicians
- Systems Controls Technicians
- Janitorial / Custodian
- Process Equipment Technicians
- Space Planner
- Security Personnel
Why Join ElevateBio?
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.