Associate Director, Sterility Assurance, Drug Product

The Role

Reporting to the Sr. Director of Sterility Assurance, the Associate Director of Sterility Assurance is tasked with leading the development and management of an aseptic and sterility assurance program for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role encompasses overseeing operational readiness for clinical and commercial production, adherence to GxP, corporate, regulatory, and industry standards, and providing cross-functional support for facility start-up activities including Commissioning, Qualification & Validation (CQV).

The Associate Director will play a crucial role in establishing a best-in-class Sterility Assurance program, implementing best practices, and building a team to achieve excellence in manufacturing operations while adhering to regulatory compliance and quality standards. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Here's What You'll Do

• Collaborate with Moderna's global and site Sterility Assurance network to drive standardization, harmonization, and best practices across sterile manufacturing operations.

• Oversee sterility assurance for drug product operations post-facility start-up, ensuring compliance with cGMPs, company procedures, and regulatory requirements utilizing QBD and contamination control risk assessments.

• Establish operational strategies, implement best practices, and lead a team to ensure excellence in manufacturing operations and regulatory compliance.

• Support sterile manufacturing site operations by providing expertise in aseptic processing and behaviors, training development, and guidance in sterility assurance.

• Drive continuous improvement of aseptic techniques and practices to maintain product sterility.

• Provide input for the design of critical utilities and controlled environments and cleanliness control strategies.

• Provide input for the design of bioburden-controlled manufacturing processes and sterile fill/finish and packaging technologies, including container-closure integrity and visual inspection.

• Lead the design and execution of environmental monitoring programs.

• Manage CAPAs, and support regulatory inspections and audits.

• Monitor regulatory trends in sterility assurance, adapting strategies as needed.

• Develop and manage budget for sterility assurance and environmental monitoring functions, ensuring resource efficiency.

Here's What You'll Bring to the Table

• Bachelor's degree in Microbiology, Biology, Pharmacy, or related field; advanced degree (MS or PhD) preferred.

• At least 10 years' experience in the pharmaceutical or biotech industry, focusing on sterility assurance, aseptic processing, and environmental monitoring.

• Strong knowledge of cGMP regulations, ISO standards, USP <797> and <1116>, and other relevant guidance documents.

• Experience participating in inspections as a Microbiological Subject Matter Expert (SME) and direct interactions with world-wide Health Authorities with diverse global authority (e.g. FDA, MHRA, EMA, PMDA, ANVISA)

• In depth knowledge and expertise in aseptic processing and sterile operations including syringe/vial filling isolators and manual filling.

• Expertise in design, qualification and control of clean facilities and critical utilities.

• Experience in data analysis and statistical evaluation and trending of microbiological data.

• Experience in sterility assurance validation (terminal, aseptic, and/or reprocessing) and environmental controls for pharmaceutical manufacturing facilities.

• Competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).

• Experience with conducting technical/risk assessments of in-house and contract sterilization processes or contract microbiological laboratories (preferred). Expertise in investigations/deviation management including, writing, and evaluating microbiological OOS's and laboratory investigations and manufacturing investigations.

• Prior experience with authoring and reviewing of Quality-owned regulatory filing sections.

• Strong knowledge in microbiological analytical method lifecycle (including rapid microbiology methods preferred).

• Capability to lead, educate, train, and develop a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.

• Ability to think critically and demonstrate troubleshooting and problem-solving skills. Excellent ability to communicate issues in a scientifically sound and understandable way.

• Excellent project management and organizational skills.

• Ability to navigate through ambiguity and rapid growth and adapt to change.

• Proven ability to manage complex projects and engage cross-functional teams.

• Experience with budget management and cost optimization.

• Strong commitment to quality, safety, and continuous improvement.

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!

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