Sr. Manager, QC
ModernaTX, Inc.

Norwood, Massachusetts

Posted in Science and Research


This job has expired.

Job Info


The Role

Moderna is seeking a Senior Commercial Quality Control Manager for a position based at Norwood, MA site. Reporting to the Director of Quality Control, this role will be responsible for leading the Commercial QC Chemistry Lab Operations team. The individual will directly oversee laboratory functions in shift operation to support in-process (STAT), release and stability testing of drug substances, process intermediates and finished drug products under cGMP regulations

Here's What You'll Do

  • Manage Commercial QC operation team in compliance with US and international regulatory guidelines and Moderna standard operating procedures
  • This position requires on-site presence
  • Oversee the implementation and maintenance of laboratory testing capabilities that employ state-of-the-art instrumentation and digital infrastructure
  • Provide technical and operational expertise for training and developing staff, assisting in troubleshooting, and performing investigations
  • Participate in cross functional planning to align laboratory resources and constraints with business objectives.
  • Responsible for delivering quick turnaround, forward in process (STAT) testing results to support commercial manufacturing
  • Oversee the lab scheduling and sample shipments to ensure commercial release and stability testing completed within required timelines
  • Manage lab investigation program and root cause trending (OOS/OOT/OOE/Lab Events) to ensure lab quality events are investigated properly and closed on time
  • Manage authoring of quality systems records such as deviations, change controls, CAPAs and perform effectiveness check
  • Manage continuous improvement projects to reduce lab errors, increase team working efficiency and improve compliance
  • Review and approve methods and procedures, to ensure compliance with Moderna policies and procedures, regulatory guidelines as well as current industry standards
  • Oversee inspection readiness activities, participate in regulatory/internal audits, and prepare the audit responses
  • Writes technical/investigation reports and reviews and revises standard operating procedures as needed.
  • Participate in and partner with the Digital team to expand and optimize the use of the LIMS (LabVantage) and other digital execution systems
  • Review Executed assay packages, in both paper and electronic formats including review of chromatography data and other analytical outputs
  • Establish and maintains a safe laboratory working environment
  • Additional duties as may be assigned from time to time

Here's What You'll Need (Minimum Qualifications)
  • Minimum BS/BA in Science degree, prefer in Chemistry
  • Minimum 10-15 years in cGMP Pharmaceutical QC laboratory.
  • Minimum 5 years in a leadership role.

Here's What You'll Bring to the Table (Preferred Qualifications)
  • In-depth knowledge of relevant FDA, EU, ICH, USP and EP guidelines and regulations.
  • Extensive experience, solid technical knowledge and strong troubleshooting ability for analytical methodology with demonstrated proficiency with QC Pharmaceutical Chemistry
  • Proficiency and experience with scheduling, planning or project management skills, including detailed instrument and analyst scheduling.
  • Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.
  • Experience with statistical data analysis
  • Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
  • 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
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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 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.

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This job has expired.

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