Supervisor, Manufacturing, Clinical Drug Product

BioSpace; Norwood (MA); On-site; USD 80,000 - 90,000; Full time

Job summary

A growing biopharmaceutical company is looking for a Supervisor, Manufacturing, Clinical Drug Product. You will lead a team accountable for manufacturing cGMP mRNA medications, ensuring adherence to regulatory standards and operational success. This role requires strong leadership and cGMP knowledge in a fast-paced environment.

Benefits

Best-in-class healthcare coverage

Family planning and adoption benefits

Generous paid time off

Lifestyle Spending Accounts

Access to fitness and mindfulness support

Qualifications

• Minimum 3-5 years’ industry experience for STEM degree.
• 5-8 years’ industry experience for Associates’ degree.
• 8 years’ industry experience for HS Diploma.

Responsibilities

• Supervise the vial filling, visual inspection, labeling, and packaging operations.
• Ensure resources are efficiently utilized for on-time delivery.
• Oversee hiring, training, and performance of manufacturing staff.

Skills

Team Leadership

Communication

Problem Solving

Education

STEM degree

Associates’ degree

HS Diploma

Job description

Supervisor, Manufacturing, Clinical Drug Product

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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 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 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.

Our Working Model

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 [e-mail].

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

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