Manufacturing Associate II, Drug Substance Operations

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. The Individual executes independently and proficiently 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.

Heres What Youll Do

• Practice safe work habits and adhere to Modernas 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 tasks 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.
• Perform specific unit operations in which they are fully trained.
• Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies including 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.

Heres What Youll Need (Basic Qualifications)

Education: HS Diploma

Experience: STEM degree with 2-3 years industry experience or an Associates degree with 3-5 years industry experience or HS Diploma with 5 years industry experience

Specific Certifications or Training: None

Other Quantifiable Preference: Working understanding of GMP regulations.

This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.

At Moderna we are focused on delivering on our mission by enabling talent to thrive. For this role we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

Pay & Benefits

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

• Best-in-class healthcare coverage 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 investment opportunities to help you plan for the future

• Location-specific perks and extras

The salary range for this role is $63200.00 - $100900.00. 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 individuals 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.

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 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 persons 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 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

Were 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 .

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 applicants 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. #LI-KH1

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