AddressThe Role
Moderna is looking for a Specialist, Quality Control Microbiology for their Marlborough, MA facility. This role will support in-process and release testing for raw material, drug substance and mRNA drug products produced at Moderna’s commercial manufacturing facility. 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 Individualized Neoantigen Therapy (INT) program.
Here’s What You’ll Do
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 other QC Microbiology staff.
Assist in equipment qualification / validation activities, including maintenance.
Perform routine environmental monitoring and critical utility sampling activities.
Conduct analysis of water samples to include TOC, Conductivity, Bioburden, and Endotoxin
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.
Here’s What You’ll Bring to the Table:
BS in a relevant scientific discipline (Microbiology preferred) with a minimum of 4 years (or MS in a relevant scientific discipline with 2 years) Quality Control experience in a cGMP organization focused on Microbiology.
Standard microbiological product testing (bioburden, endotoxins, and sterility).
Aseptic technique.
Proficiency with Microsoft Office Programs.
Familiarity with electronic databases (e.g. LIMS, ERP, LMS, or equivalent software).
Strong written and oral communication skills as well as organizational skills.
Practical working knowledge of QC Microbiological instrumentation and related software.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Desired Attributes:
Commitment to safety and quality.
Vision for continuous improvement and innovation.
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
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
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!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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