Moderna is seeking a cGMP Manufacturing Associate I, in the Fill Finish Operations, Drug Product group 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 2nd shift Sunday - Wednesday, 2pm - Midnight
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 focusing through execution of sterile filtration and vial filling 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:
Here's What You'll Bring to the Table:
- Routinely execute sterile filtration and filling, using disposable technologies, automation, and Manufacturing Execution Systems (MES)
- Demonstrate general knowledge of standard manufacturing practices and equipment.
- Tracking and reorder of all filling materials.
- Perform fill finish activities for multiple drug product vial types and packaging configurations.
- Collaborate with Supply Chain and maintain inventory.
- Closely partner with QA and QC peers for execution of fill finish activities.
- Support the investigation and troubleshooting of technical and compliance issues.
- Maintain individual training compliance.
- Ensure strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
- Follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
- Ability to work in a fast-paced environment and drive for continuous improvement.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- Adhere to gowning procedures and maintain a clean general operating area.
- Flexibility to work off hours and overtime if needed to meet clinic demand and process schedules.
- Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry, or related field, with 0 to 2 years related experience.
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
- Exceptional written, oral communication, and organizational skills required.
- Express Moderna's core values: Bold - Curious - Relentless - Collaborative.
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.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 www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.