Quality Control Associate, Bioanalytical
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 Quality Control Associate, Bioanalytical to join our growing team!!!
AmplifyBio’s next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy 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 South San Francisco, CA.
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.
- Execute written protocols for analytical procedure development, qualification/validation, and technology transfer.
- Conduct 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’s.
- Contribute to the QC laboratory maintenance and the lab operations 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:
- A bachelor’s degree in biological sciences, or related field with at 1+ years of relevant experience.
- Have experience performing analytical procedures in pharmaceutical, biotechnology industry, or academic laboratory. Preferred to have hands on experience with biological or cell biology analytical methodologies in a regulated laboratory setting.
- Excel in a fast-paced team environment, have a high degree of attention to detail.
- Are highly self-motivated to deliver on objectives to meet or exceed timelines.
- Comfortable working in a regulated environment, with high degree of attention to detail.
- Demonstrated problem solving ability and performance in a fast-paced working environment.
- Familiarity with cGMP and necessary for the operation of a QC Microbiology group.
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.
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)
- 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!!!