Associate I, Quality Control Stability
Reporting to the Senior Manager of Quality Control, the Quality Control Stability Associate will be responsible for supporting GMP stability testing programs and Quality Systems, including the maintaining of stability databases, performing data trending and statistical analyses, creation and review of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations. This individual will also support the implementation and functionality of stability related processes, equipment and systems at both the Cambridge, MA and Norwood, MA locations. This position will start in Cambridge, MA and transition to Norwood, MA.
Here's What You'll Do:
- Performs stability responsibilities in compliance with stability program and associated SOP's.
- Creates, reviews and revises stability protocols and reports.
- Assists with reporting of stability testing results both externally and cross-functionally.
- Performs the required functions for stability studies in LIMS, including data entry and review.
- Performs trending of stability data and statistical analyses and maintains/ keeps current stability tables and charts for all stability studies.
- Scans and organizes stability protocols, CoA's and reports to appropriate folders in database in a timely manner.
- Assists and performs stability set down and stability pull activities to include, but not limited to labeling, verifying sample quantities and updating in LIMS and/or appropriate logs/inventory sheets.
- Assists with creating stability schedules for GMP stability drug substance and drug product and ensures stability sample pulls occur as scheduled and within appropriate timelines.
- Requests and retrieves stability testing data/reports from external vendors and shared folders and updates in-house stability binders and databases accordingly.
- Provides support to applicable stability sections of regulatory submissions.
Here's What You'll Bring to the Table:
- BS with a minimum of 1 year of Quality Control experience in a cGMP Biotech or Pharma with a focus on Stability.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- Proficiency with Microsoft Office Programs
- Working knowledge of statistical analysis, e.g. Excel, PowerPoint, Minitab for performing trend analysis and reporting of stability data.
- Familiarity with electronic databases (e.g. LIMS, EDMS, SAP) preferred.
- Ability to communicate issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written).
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
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.