Associate II, Quality Control

Initial Therapeutics, Inc.; Marlborough (MA); On-site; USD 63,200 - 100,900; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Discretionary bonus/equity

Job summary

Moderna in Marlborough, MA is seeking a candidate to support cGMP microbiology methods for QC raw materials, plasmid, drug substance, stability, and finished product testing for mRNA products, plus environmental monitoring at Moderna’s manufacturing facility. This role operates on a 10-hour shift and may involve non-testing projects.

You will perform compendial microbiological testing (Endotoxin, Bioburden, EM), microbial identification, culture purity, and support testing for in-process

Qualifications

• BS in a relevant scientific discipline with 0–2 years QC experience in a cGMP organization.
• Excellent troubleshooting and ability to communicate issues scientifically.
• Familiarity with electronic databases (LIMS, SAP, LMS or equivalents).
• Strong written and oral communication and organizational skills.
• Ability to prioritize and manage multiple projects in a fast-paced environment.
• Working knowledge of FDA, EU, ICH guidelines and regulations.

Responsibilities

• Execute compendial microbiological testing and other methodologies as needed.
• Perform methods such as Endotoxin, Bioburden, Environmental Monitoring, Microbial identification, Culture Purity.
• Support testing for in-process samples, drug substance and drug product.
• Assist in development, implementation and maintenance of laboratory systems per cGMP.

Skills

Troubleshooting

Communication

Time management

Regulatory knowledge

Education

BS in a relevant science

MS in a relevant science

Tools

LIMS

SAP

LMS

Job description

The Role

Moderna is seeking a Candidate based at their Marlborough, MA site. The Individual will support cGMP microbiology methods for QC raw material, plasmid, drug substance, Stability, finished product testing for mRNA products produced and Environmental and critical utilities monitoring at Moderna’s manufacturing facility. This individual will contribute to non-testing projects and activities as needed example document certification, monthly biosafety cabinet cleaning etc. This position will be working a 10-h Shift.

Here's What You’ll Do

• Execute compendial microbiological testing, and other methodologies as needed.
• Perform methods such as Endotoxin, Bioburden, Environmental Monitoring, Microbial identification, Culture Purity,
• Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies.
• Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.
• Perform general laboratory support activities including reagent preparation, equipment maintenance, weekly and monthly cleaning of the BSCs, Document Certification etc.
• Stock and perform inventory of lab supplies.
• Establish and maintain a safe laboratory working environment.

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

• BS in a relevant scientific discipline with a minimum of 0 - 2 years (or MS in a relevant scientific discipline with 1 year) Quality Control experience in a cGMP organization
• Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.
• Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software)
• Strong written and oral communication skills as well as organizational skills
• Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment efficiently and independently.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and 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 $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.

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 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. 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

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 NoticeThis 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.#LI-KH1