The Role:

MTC-S Drug Substance Operations is responsible for the execution of processing and combining mRNA and LMX/LNP for clinical pipeline products as well as commercial seasonal vaccines in a GMP regulated environment.A Sr. Manufacturing Associate I, executes, independently and expertly, all applicable manufacturing unit operations, as directed, following relevant standard operating procedures and cGMP regulations.  The work is conducted within a clean-room environment and typically involves limited physical activity, 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 GMP 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 moderately complex troubleshooting and assists investigations as required.

• As required, perform all end to end clinical & commercial drug substance unit operations.

• Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies involving chromatography, multiple filtration methods and nano-mixing operations.

• Filling and dispensing activities to final container closure for finished clinical and commercial drug substance prior to forward processing. 

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

 

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

• Education: HS Diploma

• Experience: STEM degree with 4 years’ industry experience or an Associates’ degree with 5-8 years’ industry experience or HS Diploma with 8 years’ industry experience 

• Specific Certifications or Training:  None 

• Other Quantifiable Preference: Strong understanding of GMP regulations.

Pay & Benefits

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

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

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