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, Engineering 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 talented GMP Engineering Leader within the biotech / pharmaceutical industry with strong engineering expertise and a solid technical background.
What You’ll Do Here:
- Provide hands on leadership and expertise in regard to Engineering related functions such as CAPEX Projects, Calibration, Automation and Equipment and Facilities / Utilities Qualification.
- Develop and demonstrate compliance with Standard Operating Procedures (SOPs) associated with Equipment Validation, Change Control, CMMS, Site Calibration / Metrology Program, EH&S and CAPEX Management.
- Manage and lead Capital Engineering Projects to support both client and business needs.
- Be responsible for IQ/OQ/PQ, commissioning, qualification, and lifecycle validation of GMP facilities and equipment.
- Manage and oversee all master data associated with the CMMS (Computerized Maintenance Management System) regarding critical assets, work / calibration plans and report management. Blue Mountain Regulatory Asset Management system experience a plus but not required.
- Develop and oversee site’s EH&S policies by establishing a culture of safety and ensuring regulatory compliance with all applicable agencies.
- Ensure effective communication and project plan alignment between all external client and internal business stakeholders.
- Ensure compliance regarding required change control and/or deviation management for all Engineering and Facilities / Utilities related items.
- Responsible for overall strategy and management of business and/or regulatory critical automation systems such as Building Management Systems (BMS), Environmental Monitoring Systems (EMS), card access and video surveillance.
- Oversee and manage direct reports and third-party service providers to ensure compliance.
- 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:
- BS or MS in Engineering or related field with 6+ years’ experience in GMP Engineering related activities such as Capital Project Management, Equipment / Utility Qualification / Validation, Calibration / Metrology, CMMS Management and/or Automation.
- Proven track record of establishing and maintaining applicable Engineering related SOPs to demonstrate compliance.
- Expertise in FDA cGMP regulations and requirements for manufacturing facilities that includes understanding of cGMP compliance within a regulated environment.
- Experience managing and implementing CAPEX projects within a corporate environment.
- Experience with biotech/pharma would be desirable, cell and gene therapy experience are a plus.
- Demonstrated collaborative approach with critical business partners such as Quality, Manufacturing, IT and Supply Chain.
- Familiarity with a Quality Assurance system such as Veeva, Trackwise, MasterControl is desirable.
- Must be able to work on highly complex problems in a variety of situations where detailed engineering analysis is required. Ability to resolve complex problems using engineering principles and rational judgement, leading to successful and specific recommendations.
- Good track record of building and leading a high performing internal and/or external team and culture.
- Excellent English verbal and written communication skills.
- Proven ability to achieve results through positive influence in a matrix environment.
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!!!
