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.
What You’ll Do Here:
- Managing EHS programs by leveraging external vendor. Programs include waste management, daily health and safety, and site safety procedures.
- Coordinating GMP calibration and validation program utilizing both external vendors contact as well as direct hands-on execution of relevant studies and documentation.
- Assisting management in execution of Computerized Maintenance Management System (CMMS) program providing documentation, troubleshooting, and other support as needed
- Budgeting, planning, and executing facility capital and expense projects driving project completion as priorities change or are identified.
- Be the first line of contact for equipment support and communicate with operations staff and engineering teams to perform troubleshooting and solve equipment related issues.
- Writing and performing verification and validation test protocols and reports including IQ/OQ/PQ.
- Improving tools, reporting, and operational documents for tracking spare parts, service calls, and repair decision-making.
We Would Love to Hear from You If:
- Bachelors of Science degree in Engineering, Biology, Chemistry, or related field of study.
- Minimum of 5 years industry experience supporting production as well as laboratory operations.
- Experience with CMMS systems (SAP PM, Blue Mountain, etc.).
- 2+ years’ experience executing calibration/validation activities.
- Experience working in a regulated environment (GxP/GMP).
- Highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives.
- Have great communication skills working with cross-functional teams and presenting data to a diverse audience.
Desired But Not Required:
- Experience supporting EHS activities on a site wide basis. Understanding of permitting processes and dealing with safety authorities (OSHA, local government, etc.).
- Experience dealing with pharmaceutical regulatory bodies (FDA, EMA, etc). Audit level support is a plus.
- Experience using incident tracking software Veeva or similar.
- Experience with the principles of continuous process improvement (Lean, Six Sigma, or QbD).
- Experience supporting and deploying hardware into production environments with robust validation/verification requirements (cGMP, CLIA, CAP, ISO 13485) and stringent IQ/OQ/PQ.
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!!!