Reporting to the Senior Manager of Quality Control, Microbiology, the QC Microbiology Specialist will support in-process and release testing for raw material, drug substance and mRNA drug products produced at Moderna's manufacturing facility and affiliated contract organizations. This position will assist management in ensuring the goals and milestones are met for the QC Microbiology Lab as well as day to day operations and support Moderna's Personalized Cancer Vaccine program. This position will be 12-h Day Shift.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Utilize QC Microbiology knowledge and investigational skills to identify and resolve testing issues and drive continuous improvement in laboratory operations.
- Support testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies.
- Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
- Perform on the job (OJT) training and act as a mentor to QC Microbiology staff
- Assist in equipment qualification / validation activities, including maintenance
- Assist with scheduling and resource allocation
- Work directly with management to ensure QC goals and milestones are met
- Lead and organize continuous improvement projects
- Troubleshoot issues related to equipment, laboratory procedures and assay performance
- Write/revise SOPs, technical protocols and reports
- Assist with audit preparation and regulatory compliance
- Responsible for alarms in the QC Microbiology Lab
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- BS in a relevant scientific discipline with a minimum of 4 years (or MS in a relevant scientific discipline with 2 years) Quality Control experience in a cGMP organization with a focus in Microbiology
- 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.