Specialist, Clinical Quality Control, Stability

The Role:

Reporting to the Senior Manager of Quality Control Stability, the Quality Control Stability Specialist will be responsible for supporting GMP stability testing programs and Quality Systems, including the maintaining of stability databases, performing data trending and statistical analysis, creation of SOPs, stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations. This individual will also lead and support the implementation and functionality of stability related processes, equipment and systems at the Norwood, MA location and new sites as applicable.

Heres What Youll Do

• Reports stability data and performs trending and statistical analysis

• Creates, reviews and revises stability protocols and reports, specification documents through initiation of document change requests

• Contributes to and supports activities needed to facilitate routine stability team meetings

• Maintains an accurate inventory for all GMP Stability drug substance and drug products that are received, stored and removed for testing

• Coordinates timely shipment of samples to external labs for testing based on stability pull schedules

• Requests and retrieves stability testing data/reports from external vendors and updates shared site folders including stability data tables and LIMS

• Creates and maintains stability schedules for GMP stability drug substance and drug product and ensures stability sample pulls occur as scheduled and within appropriate timelines.

• Leads and assists with stability pulls, set- downs, aliquoting, labeling, and distributing of samples to the stability chambers and appropriate analytical laboratories

• Assists with maintenance, calibration and operation activities for stability chambers to include unit performance

• Performs the initiation and management of stability studies in LIMS and performs data entry and review

• Leads and assists with compiling metrics for quarterly QMR and cross-functional team meetings

• Conducts and assists with initiation and closure of deviations, laboratory investigations and CAPA

• Provides support to applicable stability sections of regulatory submissions

• Assists with Reference Standard Program management

Heres What Youll Bring to The Table

• BS with a minimum of 5 years Quality Control experience in a cGMP Biotech or Pharma with 2+ years focus on Stability.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• 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 winter shut down
  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 persons 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.

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