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Sr. Manager, QC Stability

3 months ago

Norwood, United States Moderna, Inc. Full time

The Role:

The Senior Manager will manage operational oversight of the clinical and commercial stability programs within the Norwood Quality Control team. He/she/they will be responsible for leading and overseeing all technical and operational aspects of the in-house stability program for clinical and commercial products. The Senior Manager will interact closely with partners within Global Stability, Analytical Development, Digital and various teams within QC.

Heres What Youll Do:

Manage and lead the day-to-day operations of the Norwood QC clinical and commercial stability program including and not limited to stability study initiations, pull and setdown schedules, stability protocols, program metrics, stability data reporting and trending, stability assessments for expiry extensions and investigations, change control assessments and other quality systems as required.

Responsible for management of stability data using LIMS system and other digital tools as required; compilation of reports and trending for both internal and external reporting purposes such as expiry evaluations, OOS/OOT investigations, regulatory filings, regulatory commitments, annual product quality reports, and more.

Author, review, revise and approve various documentation related to stability program operation including stability protocols, reports, specifications, SOPs, expiry and shelf life assessments.

Track, monitor and report on stability program metrics and KPIs; effectively utilize metrics and KPIs to identify areas for continuous improvement and implement corrective or preventative action plans.

Support various quality systems as related to the stability program including deviations, OOS/OOT investigations, change controls, CAPAs and effectiveness checks ensuring on-time record metrics achieved.

Collaborate closely with clinical and commercial program teams to consistently meet timelines for availability of critical stability data needed to support filings and commitments.

Partner with Norwood QC lab teams to drive on-time testing and review of stability samples.

Serve as QC stability program subject matter expert for health authority inspections as well as team guidance and mentorship.

May lead or support internal or cross functional projects related to the stability program.

Other duties as assigned.

Heres What Youll Need:

Advanced degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy) or related field.

BS with 8-10 years, MS with 6-8 years in cGMP Quality Control environment with 1-3 years in a leadership role.

Extensive knowledge of GMP regulations, ICH guidelines, and stability testing requirements.

Proven track record of managing stability programs and COA processes for clinical and commercial products.

Strong leadership skills with the ability to inspire and lead teams.

Excellent organizational, communication, and problem-solving skills.

Ability to work effectively in a fast-paced, dynamic environment.

Experience with regulatory inspections and interactions with health authorities.

This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.

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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras

About Moderna

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.

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. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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