Do you want to be part of a growing world-class organization focused on bettering our world? 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 newly established, commercially focused preclinical CRO that was created as a Battelle spin-off. Aligned with, and supported by leading life sciences-focused investors, we partner with our clients to provide preclinical CRO services from single study and through full IND enabling studies. We have a strong focus and commitment to helping accelerate the commercialization of advanced therapies such as cell and gene therapies and vaccines.

Moving forward we will combine continuous improvement and innovation to become the preferred preclinical CRO in the industry, by working in partnership with our clients, and 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 is seeking to hire a Provantis System Associate to join our growing team!!!

The Provantis System Associate is responsible for working with the Provantis System Administrator to provide support in the day-to-day operational performance of the electronic Provantis System in compliance with regulations, policies, and procedures. The Provantis System Associate will be involved with validation efforts, deviations, investigations, and change control efforts.  The successful candidate will be self-directed, a great team player, and have excellent communication skills. The ideal candidate will have experience in pharmaceutical, biotechnology, life sciences and/or FDA regulated industries.

What You’ll Do Here:

• Provide backup support to the business process owner of the Provantis system, drive and facilitate the overall configuration, design, and functionality.
• Support and test all new product updates and releases.
• Work directly with support teams to bring open issues to a resolution by triage and monitoring progress.
• Work with end users and stakeholders to understand and verify business needs and provide effective, efficient requirements.
• Support and collaborate with IT for maintenance and validation activities within the system.
• Assist with creation of GxP documents (SOPs, Policies, Change Control Documents) as required.
• Assist the Quality Operations team to monitor and maintain the quality system and other quality duties, as assigned.
• Collaborate with the Provantis System Administrator to interpret business goals and requirements and devise technical solutions.
• Review, update, and disseminate system knowledge.
• Prepare and/or maintain documentation pertaining to systems operation and user documentation; translate business specifications into user documentation.
• Prioritize and manage multiple concurrent projects and day-to-day requests.

We Would Love to Hear from You If:

• Minimum BS/BA degree with an emphasis in Quality, Biology, Chemistry, or related scientific discipline.
• 3+ years of experience hands on work with the support or implementation of software systems preferably in a scientific GxP environment.
• Experience with 21CFR Part 11, regulatory compliance, and validation standards.
• Proven multidisciplinary teamwork and strong communications skills.
• Ability to work effectively with minimal oversight and proactively seek feedback from management.
• Excellent interpersonal skills, including strong communication skills (verbal/written).
• Ability and experience working independently as well as in a team environment
• Ability to support system configuration for evolving SEND (Standard Exchange of Non-Clinical Data) requirements.

At AmplifyBio, we’re committed to growing and empowering an inclusive community within our company and industry. This is why 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.  Reasonable accommodations will be considered.

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 (did we mention we have an onsite gym and ping pong table?), 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 generous PTO
• 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)
• 4 weeks paid Parental Leave
• Wellness Program
• 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!!!