AmplifyBio is a company dedicated to building an integrated environment where clients can access technologies, platforms, capabilities, and safety testing for the scale up and commercialization of advanced therapies. We began as a CRO, spun out from the Battelle organization in West Jefferson, Ohio and are now proud to have added a site in South San Francisco dedicated to discovery, optimization, and characterization of client drug candidates and soon to launch facility in New Albany, OH.
The platforms and domain expertise at our New Albany site will fill the critical gap that exists between discovery and the clinical scale up of drug development. The team here is dedicated to helping clients understand the biological and immunological mechanisms and characteristics of their advanced therapies to ensure product consistency and prevent unexpected failures downstream.
We partner with our clients, leveraging state-of-the-art technologies and platforms, we will enable our customers to accelerate and improve the product development cycle, from concept to commercial.
When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians and specialists across a variety of disciplines. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.
AmplifyBio’s next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy (CGT) manufacturing and development facility. We are seeking highly motivated individuals to help create and define a first-of-its-kind CGT facility at our new site in New Albany, OH.
AmplifyBio is currently seeking to hire a Sr. / Manager, Facilities Maintenance & Utilities to join our growing team!!!
This is a unique opportunity to be part of an emerging startup bringing innovative technology to advanced therapies.
We are seeking a hands-on talented GMP Facilities Maintenance Leader with biotech and/or pharmaceutical industry facilities operations expertise with solid technical foundation in maintenance and utilities.
What You’ll Do Here:
- Provide hands on oversight for facilities, maintenance and utilities associated with GxP manufacturing activities in a fast-paced technology driven environment.
- Develop and demonstrate compliance with Standard Operating Procedures (SOPs) associated with corrective / preventive maintenance, critical alarm management, pest control and equipment / facility operations.
- Schedule and execute on demand and planned corrective and preventive maintenance activities associated with equipment, utilities, and facilities in support of GMP manufacturing activities using a “hands on” approach.
- Oversee and manage direct reports and third-party service providers in order to ensure compliance and demonstrate a state of control.
- Ensure reliability of critical utilities such as boilers, chillers, process gases and emergency electrical power in order to minimize downtime and support GMP manufacturing operations.
- Utilize and manage a CMMS (Computerized maintenance management system) for planning / scheduling of corrective and preventive maintenance activities, equipment life cycle management, and spare parts management. Blue Mountain Regulatory Asset Management (BMRAM) experience preferred but not required.
- Exceptional customer service skills related to both internal and external partners.
- Develop and drive KPI (Key Performance Indicators) for maintenance, reliability and work order management.
- Ensure effective communication and alignment between key business stakeholders, such as Manufacturing, Quality, IT, Supply Chain, MSAT, Finance, HR, and all departments regarding facilities operation’s issues.
- Ensure compliance with company policy for procurement of facilities services and goods as well as local law and regulations (Building Taxes, Health, and Safety).
We Would Love to Hear from You If:
- AS or BS Engineering / Facilities Management or related field with 7+ years’ experience in GMP facilities expansion and operational management of general office, laboratory space, GMP facilities maintenance, utility systems (water, air, HVAC, etc.), and equipment life cycle management. Additional relevant years of experience may be substituted for formal education requirement.
- Proven track record of using / managing a formal CMMS (Computerized Maintenance Management System), work order system, corrective / preventive maintenance and equipment reliability.
- Expertise in FDA cGMP regulations and requirements for manufacturing-facility utilities that includes understanding of cGMP compliance within a regulated environment.
- Experience managing facilities related projects in a corporate environment.
- Experience in biotech/pharma desirable, cleanroom(s) and/or cell and gene therapy experience is a plus.
- Familiarity with a Quality Assurance system such as Veeva, Trackwise, MasterControl is desirable.
- Must be able to troubleshoot and solve complex problems in a variety of situations where analysis of data is required. Solve problems using considerable and rational judgement, leading to routine and specific recommendations.
- Good track record of building and leading a high performing team.
- Excellent English verbal and written communications skills.
- Proven ability to achieve results through positive influence in a matrix environment.
- Experience managing annual operational budgets.
- Experience in the following areas: Plant/Equipment commissioning, qualification, and life cycle management.
AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don’t discriminate based on race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required.
Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.
- Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!
- Competitive Compensation Package
- We take work-life balance seriously and we back it up with an UNLIMITED PTO policy.
- Life and AD&D insurance
- Supplemental insurance
- LiveHealth Online
- Smart Shopper (helps you shop for better medical care and earn cash rewards while you save)
- Generous paid parental leave
- Wellness and Self-Care Programs
- 401(k) match
- Tuition Reimbursement
- EAP/work-life support system
- A fun work environment where everyone’s voice matters.
- We are just getting started! More benefits on the way!
- An Opportunity to Change the World!!!
