(Contract) Specialist, Quality Control, Bioassay
Reporting to the Senior Manager of Quality Control (Bioassay), the Bioassay Quality Control Specialist will support bioassay method transfer, qualification and release testing for QC raw material, drug substance and finished product testing for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations. He/she will troubleshoot assay methods and equipment and support investigations for OOS and other non-conforming results. He/she will contribute to the implementation of bioassay testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting. This position will start in Cambridge, MA and transition to our new state-of-art, LEED certified, cGMP manufacturing facility in Norwood, MA.
Here's What You'll Do:
- Collaborates with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities, including Sequencing, qPCR, ELISA, Potency and Mammalian Cell-Based Assays as required
- Supports testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies
- Assists in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
- Assists with equipment qualification / validation activities, including maintenance
- Troubleshoots issues related to equipment, laboratory procedures and assay performance
- Conducts technical assessments of deviations and investigations
- Provides support to QC management, including the coordination and scheduling of routine testing, project management and lab operations
- Performs general laboratory support activities including reagent preparation, equipment maintenance, etc.
- Writes/revises SOPs, protocols and reports
- Trains other laboratory staff on method execution
Here's What You'll Bring to the Table:
- BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with 0-2 years) Quality Control experience in a cGMP organization with a focus in Bioassay/Molecular Biology
- Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
- Experience with Sanger Sequencing, ELISAs, qPCR, mammalian cell culture, cell-based assays and other molecular biology techniques
- Hands-on experience performing Sanger Sequencing using the Applied Biosystems 3500XL Genetic Analyzer preferred
- Demonstrated knowledge of method qualifications
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
- Proven ability to conduct investigations
- Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Excellent communication skills (verbal and written)
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.