Sr. Manager, QC Microbiology

The Role:

The Sr. Manager will lead the INT QC Laboratory Microbiological Operations team at Moderna's Marlborough, MA site. This role involves direct oversight of laboratory functions supporting QC, including in-process testing, drug substance, and finished drug product release for mRNA products. The individual will manage laboratory testing capabilities, method transfers, investigations, and troubleshooting for assays and instruments, along with environmental monitoring (EM) strategy and oversight. 

Here's What You’ll Do:

• Manage laboratory personnel including selection, performance management, mentoring, and career development.

• Develop Standard Operating Procedures and ensure personnel training to maintain compliance.

• Act as the point of contact for site EM-related topics addressing them directly or through collaboration.

• Manage quality system records such as deviations, change controls, and CAPAs.

• Lead troubleshooting of methods and equipment.

• Oversee QC testing to meet timelines.

• Review executed data packages impacting investigations, deviations, OOS, and OOT observations. 

• Participate in cross-functional planning for QC Micro resources. 

• Partner with the Digital team to optimize LIMS usage (LabVantage and MODA-EM). 

• Engage in continuous improvements of quality systems. 

• Maintain a safe laboratory working environment.

• Set and monitor clear goals and expectations for team members.

• Provide guidance and direction in alignment with organizational strategies. 

• Inspire and motivate team members.

• Establish succession and employee development plans. 

• Foster a positive, inclusive work culture promoting collaboration and innovation. 

Here’s What You’ll Bring to the Table:

• Bachelor's degree in Biochemistry, Molecular Biology, or a related scientific discipline. 

• 10-15 years of experience with a BS/BA or 8-10 years with an MS in the pharmaceutical/biotech industry, particularly in a laboratory and/or equipment automation role. 

• 7+ years of experience in a cGMP Quality Control environment, with 3-5 years in a leadership role. 

• Ability to understand GxP regulations. 

• Desire to impact a high-growth, transformational company with a bold, relentless, curious, and collaborative culture. 

• Strong leadership and management skills. 

• Excellent communication and interpersonal skills. 

• Problem-solving and troubleshooting abilities. 

• Ability to work collaboratively across departments. 

• Commitment to safety and quality. 

• Vision for continuous improvement and innovation. 

• Strategic thinking aligned with organizational goals. 

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