The Role:
A Sr Manufacturing Associate I, in the Fill Finish Operations, Drug Product group is responsible for final sterile filtration, vial filling, visual inspection, label and packaging (Fill Finish) of Moderna’s mRNA Drug Products. This position is located at Moderna’s GMP Manufacturing site in Norwood, MA. This role will be 4×10 hour 1st shift 7:00AM to 5:00PM either Wednesday-Saturday or Sunday-Wednesday. The individual in this role will be part of a cohesive team responsible for supporting GMP mRNA-based medicines for evaluation in human clinical trials through execution of sterile filtration, vial filling, visual inspection, and labeling and packaging activities. The successful candidate will be able to document all activities performed following cGMP guidelines and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Manufacturing Sciences and Technology, Quality Control, Quality Assurance, Logistics and Process Development Technology Transfer counterparts.
Here’s What You’ll Do:
Acts as a lead/participates/checks on the work of others in executing sterile filtration, filling, visual inspection, labeling, and packaging using disposable technologies, automation, and Manufacturing Execution Systems (MES).
Demonstrates advanced applicable and specific knowledge of standard manufacturing practices and equipment.
Acts as a lead/participates/checks on the work of others in fill finish activities for multiple drug product vial types and packaging configurations.
Recognized as a mentor and trainer to others and strives to make the team better.
Collaborate with Supply Chain, maintain inventory and review process orders.
Closely partner with QA and QC peers for execution of fill finish activities.
Responds rapidly and trouble-shoots routine equipment process and digital issues.
Maintain individual training compliance as well as train others in the manufacturing process.
Works autonomously within current good manufacturing practices, standard operating procedures, and manufacturing documentation.
Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Opens and investigates deviations in coordination with other functions.
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Lead/participate in multiple projects in a fast-paced environment and drive for continuous improvement.
Effectively collaborate in a dynamic, cross-functional matrix environment.
Adhere to and reinforce gowning procedures and maintain a clean general operating area.
Flexibility to work off hours and overtime if needed and ability to identify and fill workflow gaps to meet clinic demand and process schedules.
Here’s What You’ll Bring to the Table:
Bachelor’s Degree with 10 years of experience in biopharmaceutical operations, or sufficient total work experience. Degree in Engineering or Life Sciences is preferred
Extensive experience of and subject matter expertise in drug product operations
Ambitious and self-starting attitude to take on responsibilities and own process improvements.
Experience in electronic batch records, Syncade, OSI PI, eDMS, and SAP preferred.
Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP.
Express Moderna’s core values: Bold – Curious – Relentless – Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
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