Reporting to the Microbiology Manager of External QC, the Microbiology Specialist will oversee QC microbiology activities at contract manufacturing and testing organizations, supporting raw material, drug substance and drug product testing to ensure compliance with regulatory requirements and Moderna requirements.
The Microbiology Specialist will provide the microbiology expertise for External QC and Moderna.
Heres What You will Do:
Oversee QC microbiology activities at external sites (contract manufacturing and testing organizations).
Provide QC support for the writing, review and approval of all cGMP documentation including policies/SOPs, memos, method transfer and validation protocols/reports, specifications
Manage quality system records related to microbiology activities (OOS/OOT, Deviations, CAPA, and Change Controls)
Manage investigation and troubleshooting of microbiology methods and equipment to support QC operations at external sites and ensure timely notification/escalation and resolution of issues.
Manage implementation of microbiology testing capabilities and microbiology method transfer and validation.
Provide microbiology expertise in support of QC operations, manufacturing operations and environmental monitoring program for external sites and Moderna (SME, evaluation of changes, product impact assessments).
Collaborate with internal personnel and subject matter experts in Quality Control (QC), Quality Assurance (QA), Manufacturing, Science and Technology (MS&T), Analytical Science & Technology (AS&T), QA Disposition and Supply Chain (SC) to support ongoing operational activities and resolve issues related to QC testing.
Collaborate with Regulatory CMC, providing expert microbiological input to relevant sections of the dossier to ensure submission timelines and regulatory commitments are met.
The role requires approximately 10-20% international travel.
Heres What Youll Bring to the Table:
Bachelors degree in relevant scientific discipline with minimum experience of 4-5 years within microbiology quality control or Masters degree in relevant scientific discipline with minimum experience of 2-3 years within microbiology quality control
Experienced in executing microbiology quality control testing, method transfers and suitability testing within a sterile pharmaceutical industry.
Experience with sterility test, bioburden test, endotoxins test and microbiology identification.
Knowledge of relevant regulations, Pharmacopoeias (Ph. Eur, USP, JP), GMP, ICH, standards and guidelines.
Experience with environmental monitoring and rapid microbiology methods preferred
Experience working with CMOs, CLOs, vendors, and relationship management preferred
Fluency (written/spoken) in English fluency in other languages is an advantageous
A proven track record of success in managing microbiology quality control projects.
Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
A digital first and curious mindset that allows you to constantly learn and challenge the status quo.
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
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!
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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. Were 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 email@example.com. (EEO/AAP Employer)