Sr Specialist, MS&T, Investigations

The RoleThe Manufacturing Investigations team is responsible for the day-to-day operational support of clinical and commercial drug substance and clinical drug product processing and release through deviation and CAPA writing. A Sr. Specialist, Manufacturing – Investigations, independently exercises discretion and applies expert knowledge of cGMP regulations and biopharmaceutical production processes to oversee the execution of thorough investigation and root cause analyses of quality events to ensure corrective and preventative actions are identified. Intermittently, work will be conducted within a cleanroom environment and typically involves limited physical activity, lifting and standing for periods of time.Here’s What You’ll DoFollow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.Practice and promote safe work habits and adhere to safety procedures and guidelines.Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.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.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.Utilize manufacturing process knowledge and investigational skills applying techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe, to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events.Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA).Conduct document revisions and/or document management including batch production records and manufacturing procedures.Generate investigative test plans and reports, as required.No approval or delegation authority associated with this role.Additional duties as may be assigned from time to time.Here’s What You’ll Need (Basic Qualifications)STEM degree with 5-8 years’ industry experience or a Masters’ degree with 3-5 years’ industry experience.Here’s What You’ll Bring to the Table (Preferred Qualifications)2-4 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment. Comprehensive understanding of GMP regulations.A desire to make an impact as part of a high-growth, transformational company that is

Bold, Relentless, Curious, and Collaborative.This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.About ModernaSince 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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 . (EEO/AAP Employer)

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