Moderna is in search of a Manufacturing Supervisor who will spearhead a team in charge of producing cGMP mRNA medicines for assessment in human clinical trials. This role is based at our GMP Manufacturing facility in Norwood, MA. The position involves working 12-hour shifts in Drug Product Operations, ensuring night-time coverage. Shift is 6:00 PM – 6:00 AM, on a rotating 3 x 2 x 2 x 3 schedule:
- Friday-Sunday ON
- Monday-Tuesday OFF
- Wednesday-Thursday ON
- Friday-Sunday OFF
The person occupying this position will serve as a proactive, front-line leader, responsible for guiding a team in supporting drug product filling, visual inspection, labeling, and packaging within a high-velocity operation with tight deadlines to deliver mRNA medicines to the clinic. They will utilize both existing and novel knowledge of process unit operations and cGMPs to ensure technical success, strictly adhering to a Quality System that meets global regulatory standards. This individual should possess the capability to direct manufacturing associates towards achieving business objectives, fostering their personal and professional growth, and ensuring a safe and productive workplace.
This individual will take on a pivotal role in escalating the production of Personalized Cancer Vaccines (or Individualized Neoantigen Therapy, INT) at the Norwood, MA facility. They will support commissioning activities, provide training, and handle troubleshooting, all while steering daily manufacturing operations and sticking to the production schedule. Additionally, they will contribute to the recruitment and nurturing of a high-performance, adaptable manufacturing team that can keep pace with a swift manufacturing operation timeline.
Here’s What You’ll Do:
- Safeguard the production of mRNA medicines within a cleanroom environment.
- Employ electronic computer systems for executing batch records and accessing standard operating procedures on-site.
- Guarantee efficient utilization of plans and resources (including personnel, facilities, and supplies) for the manufacture of mRNA medicines, ensuring timely delivery to the clinic.
- Supervise the recruitment, training, development, retention, and performance evaluation of staff, fostering leadership and operational efficiency in manufacturing.
- Formulate SOPs and training materials in preparation for INT production ramp-up at the Norwood Facility.
- Implement 5S methodology and organize the manufacturing area, office space, and documentation storage zones.
- Review logbooks and other GMP documentation within the stipulated timeframe.
- Collaborate closely with QA peers and MS&T for the swift disposition of Moderna medicines.
- Formulate comprehensive operating plans and monitor the achievement of business and financial objectives.
- Manage inventory of consumables to ensure a consistent supply of necessary materials.
- Foster effective working relationships with both internal and external partners.
Here’s What You’ll Bring to the Table:
- A Bachelor’s degree in the sciences, typically coupled with 5-8 years of experience in all facets of the manufacturing process within a pharmaceutical or biotech environment, including leadership experience.
- Recognized Subject Matter Expert (SME) in the setup, operation, and process of aseptic filling lines, visual inspection, and labeling activities.
- Preferred experience in aseptic techniques within biosafety cabinets, laminar flow hoods, and isolators.
- Familiarity with robotics, automation, and HMI navigation is advantageous.
- Comprehensive knowledge and understanding of cGMPs and FDA guidelines in Drug Product is mandatory.
- Capable of gowning into cleanrooms.
- Proficient in computer use for various business aspects, including executing electronic batch records, viewing procedures, and reviewing and approving documents.
- Experience in electronic batch records, Syncade, OSI PI, Veeva, and SAP is preferred.
- Highly preferred to have a proven success record in leading and developing high-performing teams and/or managing complex projects in a dynamic pharmaceutical or biotech environment.
- Demonstrated success in a fast-paced production environment at a biotech/pharmaceutical company, preferably in GMP or GLP.
- An independent worker capable of resolving issues with peers on-shift and adhering to procedures.
- A proactive and ambitious attitude to take on responsibilities and drive process improvements.
- Embodies Moderna’s core values: Bold, Curious, Relentless, and Collaborative.