Quality Control Specialist (Bioassay)
Reporting to the Senior Manager of Quality Control (Bioassay), the Bioassay Quality Control Specialist will support cGMP 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. The individual will have a focus on Molecular Biology analytics, including Sequencing, qPCR and Primer Design. 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 with a high degree of independence. The individual will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development. This position will start in Cambridge, MA and transition to Norwood, MA.
Here's What You'll Do:
- Qualify and execute GMP QC Molecular Biology methods, focusing on DNA Sanger Sequencing and qPCR, but also supporting ELISA, Potency and Cell-Based Assays as needed
- Collaborate with development groups for method transfers and qualifications in support of expanding the cGMP QC Bioassay laboratory capabilities
- Support testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies
- Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
- Lead equipment qualification / validation activities, including maintenance
- As a Subject Matter Expert, troubleshoot issues related to equipment, laboratory procedures and assay performance
- Conduct technical assessments of deviations and investigations
- Provide support to QC management, including the coordination and scheduling of routine testing, project management and lab operations
- Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.
- Write/revise SOPs, protocols and reports
- Train other laboratory staff on method execution and troubleshooting
- Provide support to audit teams for internal and vendor audits
Here's What You'll Bring to the Table:
- BS in a relevant scientific discipline with a minimum of 2-5 years. Quality Control experience in a cGMP organization with a focus in Molecular Biology and DNA Sequencing
- Extensive knowledge and hands-on experience performing and troubleshooting Sanger Sequencing, preferably with the Applied Biosystems 3500XL Genetic Analyzer
- Experience with ELISAs, qPCR, and other molecular biology techniques
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Demonstrated knowledge of method transfers and qualifications
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
- Proven ability to conduct investigations
- Ability to efficiently and independently 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)
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability.
- Voluntary legal assistance plan.
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com.
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.