Posted in Other 30+ days ago.
The Role:
Reporting to the Sr. Manager, Quality Control, this individual will be responsible for facilitating rollout and assisting management of Moderna's Quality Control Digital roadmap. This role will be crucial in the enhancement of QC digital operations at the Norwood, MA site.
This role will also play a key role in lifecycle management of QC digital operations.
Here's What You'll Do:
Responsible for facilitating strategic expansion and execution of quality control digital systems and applications
Partner with Digital on cross functional digital lab systems projects
Serve as business representative for critical QC digital systems changes
Participate in digital system validation activities including business process analysis, test script development and execution
Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
Collaborate with QC subject matter resources to coordinate implementation of changes
Work collaboratively with the QC leadership team to define and defend data integrity policies and practices for Quality Control
Here's What You'll Bring to the Table:
BS/BA and minimum 5-7 years or MS with 3+ experience in cGMP environment; 2 - 4 years in a lab analyst role
In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
Experience with various digital quality systems such as LIMS, Lab Execution System, SDMS
Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.
Experience with system validation
Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.
Outstanding communication skills (verbal and written).
Ability to manage multiple projects in a fast-paced environment.
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
Here's What We'll Bring to the Table:
About Moderna:
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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Atrius Health |
ModernaTX, Inc. |
ModernaTX, Inc. |