Specialist, Manufacturing, INT Drug Product Operations

Title: Specialist, Manufacturing, INT Drug Product Operations
Location: Norwood, MA
Reports to: Manager, Manufacturing

The Role:
Reporting to the Manufacturing Manager, this individual will join a unified team dedicated to
manufacturing top-quality mRNA-based medicines for assessment in human clinical trials. The
Manufacturing Specialist will leverage their deep understanding of cGMP regulations and downstream
biopharmaceutical production processes to manage documentation that supports batch disposition,
investigations, equipment, and enhancement initiatives within manufacturing operations. Standard
working hours are from Monday to Friday during the day shift.

Here’s What You’ll Do:
Uphold and promote safe work habits while adhering to safety procedures and guidelines.

Use manufacturing process knowledge and investigative skills to identify and resolve
manufacturing issues, driving continuous improvement in process operations.

Involved in cross-functional complex investigations, determine root causes, and implement
appropriate corrective and preventive actions.

Handle document revisions and document management, including batch production records
and manufacturing procedures.

Conduct on-the-floor training with staff as necessary.

Lead cross-functional continuous improvement teams involving Engineering, Validation, Quality
Assurance, Quality Control, Facilities, and Manufacturing Science and Technology.

Operate independently with minimal supervision and direction.

Perform tasks that consistently require independent decision-making and the exercise of
independent judgment and discretion.

Monitor production processes and participate in equipment start-up, commissioning, and
validation activities.

Ensure equipment readiness for operation and assist with troubleshooting in case of equipment

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

Bachelor’s Degree with 3-8 years of experience in biopharmaceutical operations or a Master’s
Degree with 2-4 years of industry experience; a degree in Engineering or Life Sciences is

Preferred to have a proven track record of success in leading or participating in complex projects
within a dynamic pharmaceutical or biotechnology manufacturing environment.

Recognized Subject Matter Expert (SME) in the setup, operation, and process of aseptic filling
lines and labeling activities.

Proficient in computer use for various business aspects, including executing electronic batch
records, viewing procedures, and reviewing and approving documents.

Comprehensive knowledge and understanding of cGMPs and FDA guidelines in Drug Product is

Embodies Moderna’s core values: Bold, Curious, Relentless, and Collaborative.

Learn More open link in new tab