Sr. Manager of Quality Control, Bioanalytics

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 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 to hire a Senior Manager of Quality Control, Bioanalytics to join our growing team!!

The Senior Manager, QC Bioanalytics is responsible for the day-to-day management of the personnel and work of the QC Bioanalytics team and the laboratory operation performing testing for the characterization, process development, and batch release of client’s advanced therapeutics including cellular and gene therapy products. 

What You’ll Do Here:

  • Schedule day to day operations of QC Bioanalytics group personnel and equipment supporting the client’s manufacturing in the GMP manufacturing facilities.
  • Manage bioanalytical testing services provided to AmplifyBio clients, in support of process development, product manufacturing, product release, and stability evaluation.
  • Review of records of testing and studies performed by the QC Bioanalytics group to assure accuracy, completeness, and in conformance with the applicable procedures and regulatory compliance.
  • Ensure adherence to cGMP practices for the QC Bioanalytics laboratory operations and testing performed by QC Bioanalytics group.
  • Manage the technical transfer and qualification of analytical procedures for AmplifyBio clients including commissioning and qualification of laboratory equipment and instruments used in the QC Bioanalytics laboratory.
  • Implement and maintain quality systems and assure their area of responsibilities comply to those system.
  • Supervise personnel to achieve optimal productivity and proficiency, including setting personnel goals in alignment with department and company objectives.
  • Foster an empowering environment where team members develop innovative solutions that improve performance, gains team support for change.
  • Establish expectations for collaboration within the team and model effective collaboration with other teams and departments and build strong partnerships that lead to improved results.
  • Assure staff are appropriately trained to perform their work assignments and responsibilities.
  • Assure the safety of all staff working within designated spaces, including providing training and oversight of related activities and responding to safety inspections and audits.

We Would Love to Hear from You If:

  • Bachelor degree in at least one of the biological sciences, or related field with at least 8 years of relevant experience and at least 2 years of experience supervising, mentoring, and training personnel.
  • Have had hands-on experience and scientific expertise with PCR, flow cytometry, immunoassays, bioassays, or other bioanalytical methods in a GMP/GLP laboratory.
  • Highly self-motivated with strong work ethic and drive to build and lead a high performing, GMP compliant, QC laboratory operation, that exceeds the client’s expectations.
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and fosters a supportive and positive work environment within the group, QC department, and multiple AmplifyBio sites.

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.