(Contract) Sr. Associate, Quality Control
Reporting to the Supervisor of Quality Control Chemistry, this individual will be primarily responsible for executing release and stability testing as well as participating in technical transfers from analytical development (method acquisition and qualification/validation). This role will be crucial in the establishment of QC operations at the new Moderna Norwood, MA site. This position will initially be based in the Moderna Cambridge, MA location and will transition to the Norwood, MA facility by the end of August 2018.
Here's What You'll Do:
- Performs routine analytical chemistry testing including HPLC, UPLC, CE, etc.
- Supports assay acquisitions, qualifications and validations as well as special projects as assigned
- Participates in authoring quality systems records such as deviations, change controls, CAPAs
- Troubleshoots assay methods and equipment.
- Supports investigations for OOS and other non-conforming results; may assist with investigations related to CMO/contract laboratory activities
- Performs data trending and supports analysis
- Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
- Write/revise SOPs, protocols and reports
Here's What You'll Bring to the Table:
- BS/BA preferred with a minimum 2-5 years in cGMP environment
- In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Strong knowledge of digital quality systems (LIMS, QMS, ERP) preferred.
- Experience with method acquisition, qualification and 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.
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.