Director of Engineering & Facilities (GMP)

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!

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 seeking to hire a Director of Enginering & Facilities to join our growing team!!!

Our Director of Engineering & Facilities will continue advancing AmplifyBio’s expansion of manufacturing hoteling services for many modalities. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.

We are targeting a seasoned GMP facilities operations management leader with biotech industry or pharmaceutical industry facilities operations and engineering expertise and technical foundation in engineering.

The Director of Engineering & Facilities will provide, engineering knowledge, operational and technical coordination and guidance, and advanced decision-making skills; will do so to optimize facilities expansion increase much needed lab capacity, office capacity, and manufacturing capabilities.

What You Will Do:

  • Provide strategic oversight for facilities, engineering risk management, buildings and properties with direct updates to the executive management team.
  • Strategize and lead capital engineering projects and spend.
  • Be responsible for IQ/OQ/PQ and validation of facilities and manufacturing process.
  • Oversee EHS for the company and ensure compliance.
  • Ensure effective communication and project plan alignment between business stakeholders, users, Facilities Operations, maintenance, site services, securities, IT, Procurement, Finance, Legal, HR, and all departments regarding all facilities operation’s issues.
  • Oversee and manage direct reports and third-party service providers to ensure compliance.
  • Manage the direct relationship with landlords and/or property Managers, to ensure correct building maintenance and compliance with the agreements signed in the lease contract.
  • Ensure compliance with company policy for procurement of facilities services and goods.
  • Ensure compliance with local law and regulations (Building Taxes, Health and Safety).

We Would Love to Hear from You If:

  • BS or MS in Engineering or related field with 8+ years’ experience in GMP facilities expansion and operational management of office space, GMP lab facilities, utility systems (water, air, HVAC, etc.), IT systems, and equipment management.
  • Experience with a biotech/pharma would be desirable, cell therapy is an added plus but not required.
  • Expertise in FDA cGMP regulations and requirements for manufacturing-facility utilities that includes understanding of cGMP compliance within controlled space.
  • Ability to work on highly complex problems in a variety of situations where analysis is required.  Solve problems using considerable and rational judgement, leading to routine and specific recommendations.
  • Excellent verbal and written communications skills.
  • Experience managing large capital engineering projects and facilities in a corporate environment.
  • Must be an experienced leader with extensive experience of involvement with senior management.
  • Experience managing budgets and ensure projects stay within budget.
  • Experience with work order systems implementation and operation.
  • Experience in the following areas; EH&S, IQ, OQ, PQ, validation.

Desired But Not Required: 

  • Knowledge and experience working within the pharmaceutical or highly regulated sector 
  • Ability to develop schemes, systems, and programs for continuous improvement.
  • Experience with building / office moves.
  • EHS and Engineering experience is a plus.

At AmplifyBio, we’re committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone — including women, people of color, individuals with disabilities and those in the LGBTQIA+ community — to apply for our available positions, even if they don’t necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do. 

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don’t discriminate on the basis of 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!!!

Apply Today!

Scaling science for life.