Manufacturing Associate II, Drug Substance Operations

RXinsider LTD.; Norwood (MA); On-site; USD 63,000 - 101,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family planning

Paid time off

Savings plan

Location-specific perks

Job summary

Moderna is seeking a site-based role in the US for manufacturing of mRNA and LMX/LNP drug substances in a GMP environment. Responsibilities include aseptic processing, filling, and ensuring data integrity and good documentation practices.

Role requires HS Diploma and relevant experience; cleanroom work with 12-hour shifts is expected as part of rotating schedule. Immigration sponsorship is not available for this role.

Qualifications

• HS Diploma is required.
• STEM degree with 2-3 years industry experience or Associates with 3-5 years, or HS Diploma with 5 years experience.
• GMP regulations and data integrity knowledge preferred.

Responsibilities

• Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substances.
• Filling and dispensing activities to final container closure.
• Operate in a Grade C environment ensuring clean and controlled manufacturing areas.
• Follow SOPs, batch records, and documentation practices.

Skills

GMP regulations

Data Integrity

Good Documentation Practices

Aseptic processing

Education

HS Diploma

STEM degree + 2-3 years

Associates degree + 3-5 years

Tools

SAP

VEEVA

Delta V

Syncade

LIMS

CMMS

Job description

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.

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 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.
• Shift Requirement: 12-hour day shift (6:00 AM-6:00 PM), scheduled Thursday through Saturday, with every other Wednesday required as part of the rotating schedule

Here’s What You’ll 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

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

• Working understanding of GMP regulations.
• 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 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. 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 $63,200.00 - $100,900.00. 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.

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.

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.

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.