Systems Analyst/Manager, Senior

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 a Senior Systems Analyst/Manager to join our growing team!!

The Sr. Systems Analyst/Manager will be responsible for leading business process improvements for GxP Labs and Manufacturing, GxP system implementation and provide data integrity, regulatory guidance, and oversight throughout the system lifecycle (i.e., plan, implement, run & operate and retire) at AmplifyBio.

AmplifyBio is rapidly expanding its service offerings related to the discovery, translation, and development of advanced therapies such as gene and cell therapies. As part of the team, the right candidate will help support the company’s growing portfolio of service offerings and commercial capabilities. This is a unique opportunity to be part of an emerging startup bringing innovative technology to advanced therapies.

What You’ll Do Here:

  • Understand and document current state process and drive improvements including technology implementations required to automate/support improved processes.
  • Collaborate with various stakeholders (business, quality assurance, internal/managed IT, vendors etc.) to:
    • Assess and select computerized system that meets high-level business needs (and may lead technology implementation).
    • Ensure project tailoring is appropriate for the complexity and risk to accommodate full scope of work and validation requirements.
    • Drive resolution to technical issues including audit/inspection related regulatory non-conformance to computerized system (and provide technical support required during audits/inspections).
  • Monitor/maintain/support health, data integrity and regulatory compliance of GxP computerized systems in conformance with all applicable policies and SOPs.
  • Develop/own technical SOPs and validation artifacts required to implement and maintain computerized systems.
  • Lead/manage computerized system validation activities for new implementations or enhancements to existing systems.
  • Perform and author data integrity and GxP risk assessment to ensure effective requirements are captured and controls are in place to meet global regulatory requirements for GxP systems.
  • Review/approve/provide inputs to validation artifacts as defined in quality/validation plan and SOPs (collaborate with business owner, system owner and quality owner).
  • Participate in/monitor changes to all GxP systems.
  • Ensure availability of system inventory and configuration management.
  • Facilitate/develop/own/maintain training programs on validation and regulatory requirements of computerized systems.
  • Assure that all systems have quality approved operating level procedures and plans to maintain validated status of GxP computerized systems including health of such systems.
  • Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers.

We Would Love to Hear from You If:

  • Minimum BA/BS in a life sciences or engineering/computer science or similar scientific discipline (advanced degree preferred).
  • A minimum of 5 years’ experience and in-depth knowledge of data integrity requirements and GxP computer system validation, and Part 11 requirements in a Pharmaceutical or Biotech environment including understanding software development and supporting validation IT systems in manufacturing and/or laboratories.
  • In depth understanding of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulations for assigned areas.
  • Proven experience in the interpretation and understanding of GxPs for the controlled management of paper and electronic records and signatures.
  • Cross-functional experience in QC, QA, Validation and Manufacturing is desired.
  • Experience with senior leadership level interactions is desired.
  • Experience in working in a matrix organization and challenging self and others to continuously learn and improve.

Desired Skills:

  • Excellent interpersonal skills, including written and verbal communication.
  • Strong sense of ethics, diplomacy, and discretion.
  • Commitment to Quality.
  • Excellent team player attitude.
  • Ability to demonstrate strong project management focus as well as focus on execution of strategic decisions while balancing conflicting priorities.
  • Demonstrate strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
  • Ability to manage competing priorities.
  • Ability to interact effectively with Health Authorities and various stakeholders.
  • Lean Six Sigma, Project management (PMP), or other applicable professional certification.

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)
  • 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!

Apply Today!

Scaling science for life.