Sr. Specialist, Quality Control

Our mRNA platform can change everything. Every day, we create the blueprints needed to fight and eradicate diseases, and help people live healthier lives.
With 48 development programs in our pipeline, there is so much potential to reimagine how medicines are created and developed. By applying mRNA to Personalized Cancer Vaccines, we are developing an innovative approach that tailors treatment to each patient’s individual cancer.
As our work advances, our manufacturing facilities grow in both size and sophistication. Our state of-the-art campus in Norwood, MA is now expanding in Burlington to support our high-intensity drive to be creators, risk-takers and, ultimately, changemakers. Where others talk about change, we are making it happen at hyper speed.
This is your opportunity to change medicine – and to change the world. Are you ready to be unstoppable?
Moderna is offering sign-on bonuses starting at $10K for select roles within the CMC Organization.
The Role:
Moderna is seeking a Quality Control Sr. Specialist based at their Norwood, MA site to join the Personalized Medicines QC team. Sr. Specialist roles are available across Bioassay, Microbiology, Chemistry, and more. This individual may support special projects as needed.
This position will be expected to work in a highly collaborative, cross functional manner with Quality Assurance, Manufacturing, Analytical Development, Digital/ IT and Manufacturing and provide support to the entire CQC department.
Here’s What You’ll Do:

• Provide metrics/ KPI’s for trending analysis
• Complete and maintain cGMP documentation (electronic and hard copy) for work performed
• Work with Quality Assurance to close records in a timely manner
• Author, review, and maintain annual reviews on technical documents as needed
• Support the authoring and revision of equipment, method, and other laboratory procedures and reports
• Assist in process improvement projects within multi-disciplined team

Here’s What You’ll Bring To The Table:

• Knowledge of industry standards and guidelines
• Experience in authoring Chemistry and Bioassay investigations is preferred
• Strong written and oral communication skills as well as very strong organizational skills
• Ability to navigate through ambiguity and rapid growth and adapt to change
• Ability to interact effectively with all levels of personnel within the organization
• Demonstrated ability to work effectively under established guidelines and instructions
• Bachelor’s degree in a relevant scientific discipline with at least 8 years in a cGMP setting with focus in Quality Control or Quality Assurance or MS with at least 5 years’ experience
• Knowledge of General laboratory operations, Instrument and Software, Quality Events
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
• Weekend and after hours might be required
• 5+years in a manufacturing site investigator role is preferred
• Ability to think critically and demonstrate troubleshooting and problem-solving skills

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

• Volunteer time to participate within your community
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Location-specific perks and extras!
• Generous paid time off, including:
• Vacation, sick time and holidays
• Free premium access to fitness, nutrition, and mindfulness classes
• Highly competitive and inclusive medical, dental and vision coverage options
• Discretionary year-end shutdown
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Dedicated care coordination support for our LGBTQ+ community
• Adoption and family-planning benefits
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Paid sabbatical after 5 years; every 3 years thereafter
• Exclusive preferred pricing on Peloton fitness equipment
• Free parking or subsidized commuter passes
• 401k match and Financial Planning tools

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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