Remote Gmp Compliance Jobs (NOW HIRING)

The Role:

The candidate in this role will provide advanced technical expertise within the Global Engineering Technical Authority, supporting the design, implementation, and optimization of Drug Substance process technologies across Moderna's global manufacturing network. This role focuses on ensuring process and equipment designs are robust, compliant, and scalable for commercial and clinical production of mRNA and lipid nanoparticle (LNP) drug substance platforms.

The individual will act as a process engineering subject matter expert (SME), collaborating with cross-functional teams in R&D, MS&T, and Manufacturing to apply standardized design practices and deliver innovative solutions aligned with Moderna's engineering and quality standards.

Here's What You'll Do

• Serve as a technical SME for key Drug Substance processes, including In Vitro Transcription (IVT), Chromatography, Tangential Flow Filtration (TFF), Lipid Mixing (LMX), and Lipid Nanoparticle (LNP) formulation.

• Support the design, scale-up, and implementation of modular and small-scale process skids in alignment with GxP requirements and Moderna's global standards.

• Participate in the development of process flow diagrams (PFDs), P&IDs, User Requirement Specifications (URS), and Functional Requirement Specifications (FRS) for Drug Substance of manufacturing systems.

• Contribute to Clean-In-Place (CIP) system design and optimization, focusing on process safety, efficiency, and reliability.

• Collaborate with internal stakeholders and vendors to ensure equipment design specifications and automation strategies meet performance, quality, and safety objectives.

• Support root cause investigations, deviation analysis, and continuous improvement projects to enhance process performance and reliability.

• Contribute to technical reviews, design evaluations, and standardization initiatives under Moderna's Technical Authority governance model.

• Ensure compliance with GxP/GMP regulations and Moderna's quality and documentation systems.

• Maintain required training, documentation, and audit readiness.

• Mentor junior engineers and contribute to the continuous improvement of technical and operational excellence within Global Engineering.

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

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related field required. Master's degree preferred.

• Minimum of 7-10 years of experience in process engineering or manufacturing science roles in a biopharmaceutical, biotechnology, or sterile manufacturing environment.

• Hands-on experience with Drug Substance processes such as IVT, chromatography, TFF, and LNP systems.

• Proven ability to support process design and equipment specification in a regulated manufacturing setting.

• Demonstrated experience in process simulation and modeling (e.g., mass and energy balances, scale-up modeling, dynamic or steady-state process simulation) to support process design, capacity analysis, and technology transfer.

• 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)

• Familiarity with bioprocess skid design, automation, and process analytical technologies (PAT).

• Experience supporting or leading cross-functional technical projects.

• Exposure to personalized medicine or individualized manufacturing processes (e.g., INT).

• GxP/GMP compliance training.

• Strong understanding of FDA, EMA, and ICH regulations.

• Strong communication and collaboration skills across functional teams and organizational levels.

• Demonstrated ability to manage multiple technical priorities within a fast-paced, matrixed environment.

• Proven problem-solving and analytical skills to identify and resolve complex technical issues.

• Commitment to data integrity, safety, and quality excellence in all work activities.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at 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 $109,200.00 - $174,600.00. 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.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers 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 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 leavesandaccommodations@modernatx.com.

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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