Sr. Quality Control Associate, Bioanalytical

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 a Senior QC Associate in the Quality Control Bioanalytical group to join our growing team!!! 

The Senior QC Associate is responsible for performing testing following written procedures for advanced therapeutics, including cellular and gene therapy product release, stability, and process development.  As a senior member of the QC team, the Senior QC Associate sets a high standard by example for contributing to all aspects of the day-to-day laboratory operations and the creation and implementation of laboratory operations systems and procedures to ensure the QC laboratory complies with all regulatory requirements. 

What You’ll Do Here:

  • Perform routine and non-routine biological, biochemical, and chemical test methods for cellular therapy product manufacture in process, lot release, and stability purpose.   
  • Draft and execute written protocols for analytical procedure development, qualification/validation, and technology transfer, and draft written reports. 
  • Set the example for QC colleagues to work in accordance with guidelines and requirements established by FDA Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), Code of Federal Regulations (CFR), and other applicable regulatory guidance. 
  • Contribute to the QC laboratory maintenance and the lab operations systems.  Also, work with QC management to the continuous improvement of QC operations procedures and systems.   
  • Communicate clearly and concisely, both verbally and in the form of written reports, including contributing to revising laboratory procedures necessary for the operation of the QC department. 

We Would Love to Hear From You If:

  • Bachelor’s degree in biological sciences, biotechnology, or related field of study with 8 years of experience in a related field or a Master’s degree with four years of related experience.
  • 4+ years of experience in a similar QC or analytical development role in a regulated laboratory operation.   
  • Highly experienced biological science laboratory professional with in-depth knowledge of flow cytometry, PCR, and other biological methodologies for GMP and GLP use, including assay qualification/validation, troubleshooting, and panel design. 
  • Expected to maintain rigor and high quality of execution and documentation required by (GMP) and other regulatory agencies. 
  • The candidate should enjoy operating in an exceptionally dynamic and cooperative environment that is goal-driven to achieve time-sensitive objectives. 
  • Is highly dedicated to mentoring team individuals, motivating team success, and contributing in a collegial manner to the entire company. 
  • Able to communicate clearly and concisely, both verbally and in the form of written reports, including drafting and review of protocols, SOPs, batch records, and regulatory documentation to support clinical development. 
  • Ability to work in a fast-paced environment and be flexible. 

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.