Reporting to the Associate Director of Quality Control Stability, the Quality Control Stability Specialist will be responsible for supporting US and Global processes for harmonizing and integration of Commercial and Clinical stability-related activities as well as leading, owning and supporting various GMP stability testing programs and Quality Systems, including creating, implementing and maintaining of stability databases, performing data trending, initiation through closure of Quality Events, reporting of metrics, statistical analysis, creation of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations. This individual will also assist with leading, functionality and maintenance of stability related processes, equipment and systems at the Norwood, MA location. May require some travel between Modena site locations. May require weekend and holiday support. Remote and onsite support as required.
Here's What You'll Do
- Supports and performs trending and statistical analysis in accordance with stability program SOP's and ICH guidelines.
- Creates, reviews and revises stability protocols and reports, specification documents through initiation of document change requests
- Performs the initiation and management of stability studies in LIMS and performs data entry and review as required
- Ensures and supports activities for stability chamber and stability walk-in organization and maintenance and supports troubleshooting and temperature chart (Pi) data interpretation.
- Supports maintenance, calibration and operation activities for stability chambers to include unit performance
- Creates, maintains and assists with accurate inventories for all GMP Stability drug substance and drug products that are received, stored and removed for testing
- Creates, maintains and assists with stability schedules for GMP stability drug substance and drug product and ensures stability sample pulls occur as scheduled and within appropriate timelines.
- Coordinates and supports shipment of samples to external labs for testing and/or storage based on stability pull schedules.
- Supports stability pulls and set downs.
- Supports with compiling metrics in support of quarterly QMR, stability meetings and investigations.
- Conducts and assists with initiation and closure of Quality Events including, but not limited to, Deviations, laboratory investigations, CAPA and Change Controls
- Supports stability team meetings
- Requests and retrieves stability testing data/reports from external vendors and updates shared site folders including stability data tables and LIMS
- Provides support to applicable stability sections of regulatory submissions
- Assists with Reference Standard and Cell Bank Stability Program management
- Supports and participates in continuous improvement activities for the stability program.
- Ensures compliance with cGMP and safety requirements.
- Participates in audits as needed.
Here's What You'll Need (Minimum Qualifications)
- Additional duties as may be assigned from time to time
Here's What You'll Bring to the Table (Preferred Qualifications)
- BS with a minimum of 4 years Quality Control experience in a Commercial/Global cGMP Quality assurance/Quality Control Biotech or Pharma setting with 3+ years focus on Stability.
- Working knowledge of relevant EU and global regulations and ICH standards/guidelines and experience in participating in successful regulatory inspections as related to stability.
- Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
- Knowledge of clinical and commercial GMP QC stability
- Working knowledge of statistical analysis programs and software, e.g, JMP, Looker, Tableau, Statistica/Spotfire for performing trend analysis and reporting of stability data and metrics.
- Experience with and working knowledge of electronic databases- LabVantage LIMS, LabAccess, Fusion and Veeva preferred.
- Demonstrated proficiency and expertise with MS Office programs (Outlook, Powerpoint, Excel, Word.
- Experience working with worldwide CROs, vendors, and relationship management preferred.
- Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.
- Outstanding communication skills (verbal and written).
- Demonstrated ability to work with a high degree of independence.
- Excellent troubleshooting, good judgment and ability to communicate issues in a scientifically sound and understandable way.
- Directly handles administrative problems and inquiries.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Experience with Reference Standard and Cell Bank Stability Programs.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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.