Moderna is seeking a Quality Control Senior Manager for a position based at their Norwood, MA site. Reporting to the Director of Quality Control, this individual will be responsible for leading QC Microbiology Lab Operations team within the Personalized Medicine Unit. The individual will directly oversee laboratory function in support of custom raw material, process intermediate and finished drug product testing for mRNA products produced at Moderna's manufacturing facilities. The QC Sr. Manager will directly manage teams of microbiology analysts and oversee the implementation and maintenance of laboratory testing capabilities that employ rapid microbiological methods, state-of-the-art automation and digital infrastructure. The QC Manager will drive laboratory operations with focus on quality and turnaround time. The individual will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Regulatory, Analytical Science & Technology and other Technical Development colleagues.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Manage laboratory personnel and oversees their selection, performance management, mentoring, and career development.
- Oversee QC testing as required to meet timelines.
- Assist in development of appropriate Standard Operating Procedures and training of personnel to ensure compliance.
- Manage authoring of quality systems records such as deviations, change controls, CAPAs.
- Lead Troubleshooting of methods and equipment.
- Review Executed assay packages, in paper or electronic formats.
- Drive investigations and resolutions of deviations, OOS and OOT observations.
- Participate in cross functional planning to align QC resources and constraints with business objectives.
- Manage Stability testing in partnership with QC Stability Team.
- Embrace synergies across Moderna's high throughput analytical testing organizations
- Participate in and partner with the Digital team to expand and optimize the use of the LIMS (LabVantage) and digital tracking and execution systems.
- Participate in continuous improvements of quality systems (procedures and systems) to improve organization and operational effectiveness, quality assurance compliance, and regulatory and other requirements
- Establish and maintains a safe laboratory working environment
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- BS/BA degree in microbiology (preferred), biology, molecular biology or other related scientific discipline.
- Minimum 8-10 years in cGMP Quality Control environment with 3-5 years in a leadership role.
- In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Experience and technical knowledge of bioburden, sterility, endotoxin methodology with demonstrated proficiency with alternate microbiology methods preferred.
- 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.
- Experience with personalized medicine products strongly preferred
- 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.
- 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 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.
This job has expired.