The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its footprint within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.
The Microbiology & Bioassay Quality Control Analyst , reporting to the Associate Director of Quality Control, will perform Quality Control testing using various Bioassay and Microbiology techniques in a GMP testing environment for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations. This role primarily focuses on Bioassay, with future expansion to support microbiology anticipated. The QC Analyst will also contribute to related method transfers and qualification activities and may perform assigned projects.
Your key responsibilities will be:
Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, and supporting ELISA, Cell-Based Potency testing, and other methodologies as needed.
Execute GMP QC Microbiology methods, including Sterility testing, Bioburden Analysis, Endotoxin, Micro sequencing, and other general methods such as TOC and Conductivity testing.
Support testing for drug substances and drug products, generating testing data to support other studies as needed.
Conduct analysis related to Bioassay and Microbiology laboratory, including TOC, Conductivity, Bioburden, Sterility, Endotoxin, Sanger Sequencing, qPCR, ELISA, Cell-Based Potency testing, and more.
Perform routine environmental monitoring and critical utility sampling activities, if required.
Your responsibilities will also include:
Collaborate with AS&T groups on new methods transfers and participate in method transfer projects for internal and external testing labs.
Assist in developing, implementing, and maintaining general laboratory operational systems in accordance with cGMP requirements.
Provide support to audit teams for internal and vendor audits.
Prepare and ship/receive contract laboratory testing samples, including those intended for microbiological identification.
Perform general laboratory support activities, including reagent preparation, equipment maintenance, and housekeeping.
Participate in equipment and method qualifications, validations, and method transfers.
Perform data entry utilizing good documentation practices.
Support initiation/closure of quality system records such as environmental monitoring excursion notifications and deviations.
Write/revise standard operating procedures.
The key Moderna Mindsets you'll need to succeed in the role:
Prioritize the platform: This role requires a focus on ensuring all activities align with Moderna's commitment to advancing mRNA technology, emphasizing the importance of the platform over individual tasks.
Question convention: The ability to think outside the box and challenge existing protocols to improve and innovate within the QC processes will be crucial.
Here's What You'll Bring to the Table:
BSc/BA in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus in Molecular Biology, DNA Sequencing and Microbiology.
Hands-on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, and Sanger Sequencing.
Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others).
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
Working experience in a GMP environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Proven ability to conduct investigations.
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
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. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.
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 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. 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 or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at ******.
Summary
Location: Madrid - Spain; Quality
Type: Full time
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