Supervisor, Manufacturing, Clinical Drug Product

The RoleModerna is seeking a cGMP Manufacturing Supervisor to lead a cohesive team responsible for manufacturing cGMP mRNA medications for evaluation in human clinical trials. The position is based out of our GMP Manufacturing facility in Norwood, MA. This role is 2nd shift 2PM-12AM Wednesday-Saturday.The individual in this role will be hands-on front-line leader, accountable for leading a cohesive team responsible for the vial filling, visual inspection, labelling, and packaging operations for early phase clinical trial material. He/she will apply existing and new knowledge of bioprocess unit operations, such as aseptic filling and GMP labelling activities, and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. He/she will interact fluidly with peers/supervisors and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts. They will assist in hiring and developing a high-performing, flexible manufacturing team capable of meeting a fast manufacturing operation timeline.Here's What You'll DoSafely and compliantly fill and label mRNA medicinesEnsure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time to the clinic. This requires clear communication to cross functional peers on a daily basis.Oversee the hiring, training, development, retention, and performance of staff for the execution of clinical manufacturing operations.Develop batch records, SOPs, and training materials as needed for various phases of clinical programs at the Norwood FacilityClosely partner with QA peers for closure of documentation required for timely disposition of clinical batches.Develop comprehensive operating plans to ensure success of direct team and communication to other clinical platform teams. These plans will align with corporate goals and clinical trial demand.Effectively escalate information to Clinical Manufacturing management as required.Here's What You'll Need MINIMUM EXPERIENCE: STEM degree with 3-5 years' industry experience or an Associates' degree with 5-8 years' industry experience or HS Diploma with 8 years' industry experiencePosition requires working/standing in Grade C room for a minimum of 5 hours per day.Here's What You'll Bring to the Table Previous management of people and/or projects is preferred, along with a proven track record of developing, leading and sustaining a high performing teamSubject Matter Expert on the set up/use/process of aseptic filling lines and labelling activitiesThorough knowledge and understanding of cGMPs and FDA guidelines is required.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.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit /careers to learn more about our current opportunities.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@. (EEO/AAP Employer)

Created: 2024-11-02