Supervisor, Manufacturing, Clinical Drug Product

The Role

Moderna is seeking a cGMP Manufacturing Supervisor to lead a cohesive team responsible for manufacturing cGMP mRNA medications for evaluation in human clinical trials. The position is based out of our GMP Manufacturing facility in Norwood, MA.  This role is 1st shift 6AM-6PM Sunday-Tuesday and alternating Wednesday.

The individual in this role will be hands-on front-line leader, accountable for leading a cohesive team responsible for the vial filling, visual inspection, labelling, and packaging operations for early phase clinical trial material.  They will apply existing and new knowledge of bioprocess unit operations, such as aseptic filling and GMP labelling activities, and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently.  They will interact fluidly with peers/supervisors and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts. They will assist in hiring and developing a high-performing, flexible manufacturing team capable of meeting a fast manufacturing operation timeline.

Here’s What You’ll Do

• Safely and compliantly fill and label mRNA medicines

• Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time to the clinic. This requires clear communication to cross functional peers on a daily basis.

• Oversee the hiring, training, development, retention, and performance of staff for the execution of clinical manufacturing operations.

• Develop batch records, SOPs, and training materials as needed for various phases of clinical programs at the Norwood Facility

• Closely partner with QA peers for closure of documentation required for timely disposition of clinical batches.

• Develop comprehensive operating plans to ensure success of direct team and communication to other clinical platform teams.  These plans will align with corporate goals and clinical trial demand.

• Effectively escalate information to Clinical Manufacturing management as required.

Here’s What You’ll Need (Basic Qualifications)

• HS Diploma

• MINIMUM EXPERIENCE: STEM degree with 3-5 years’ industry experience or an Associates’ degree with 5-8 years’ industry experience or HS Diploma with 8 years’ industry experience

• Position requires working/standing in Grade C room for a minimum of 10 hours per day.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Previous management of people and/or projects is preferred, along with a proven track record of developing, leading and sustaining a high performing team

• Subject Matter Expert on the set up/use/process of aseptic filling lines and labelling activities

• Thorough knowledge and understanding of cGMPs and FDA guidelines is required.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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 a