Manufacturing Associate I, Drug Product

The Role

In this role, you will execute, proficiently under guidance, all applicable manufacturing unit operations, following relevant standard operating procedures and cGMP regulations. The work is conducted within a clean-room environment and typically involves limited physical activity including lifting and standing for periods of time.

Here’s What You’ll Do

• Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.

• Follow all relevant cGMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Execute tasks precisely. Utilizing reader-doer for all steps outlined in standard operating procedures, work instructions, and batch execution documentation. Readers are responsible for SOP and batch record compliance, verifying the actions of the Doer, and are accountable for the outcome of the tasks. Doers are responsible for task execution, are expected to understand the task's purpose and are expected to be able to anticipate system response once actions are performed.

• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

• Working in grade C environments and ensuring the manufacturing area is clean and remains in a state of control.

• Adhere to documented waste handling procedures and respect environmental regulations.

• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision if applicable.

• Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.

• As a Qualified Trainer, perform On The Job Training (OJTs) to accelerate the assimilation and training of colleagues on unit operations and supporting business processes.

• Understands physical and digital systems governing equipment and processes to enable basic troubleshooting.

• Aseptic processing of drug product using filling isolators and biosafety cabinets.

• Visual inspection of filled drug product to accept or reject for further processing.

• Packaging and labeling activities for finished drug products prior to shipment.

• Able to approve document revisions as delegated by their manager.

• Additional duties as may be assigned from time to time

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

• STEM degree with 0-2 years’ industry experience or an Associates’ degree with 0-3 years’ industry experience or HS Diploma with 0-4 years’ industry experience

• For those involved in VI, they are required to be able to demonstrate 20/20 near vision and color vision with correction if necessary.

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

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

• Basic understanding of cGMP regulations.

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

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