Reporting to the Moderna is seeking a Supervisor of Manufacturing to lead the manufacturing operations of Personalized Cancer Vaccine production. This is a hands-on front-line management position; he/she is accountable for leading both first and second shift teams in support of a fully automated, fast paced and short turnaround operation to deliver a personalized cancer vaccine on time to the clinic. The individual in this role will lead a cohesive team responsible for manufacturing cGMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. They will play a key role in the ramp up of phase 2 manufacturing; supporting start up activities while leading day to day manufacturing operations. They will hire and develop a high-performing, flexible manufacturing team capable of meeting a fast manufacturing operation timeline.
Here’s What You’ll Do:
- Practice and promote safe work habits and adheres to safety procedures and guidelines
- Safely and compliantly produce mRNA/LNPs
- Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time to the clinic
- Oversee the hiring, training, development, retention, and performance of staff for the leadership and execution of manufacturing operations.
- Develop batch records, SOPs and training materials for the Norwood Facility
- Closely partner with QA peers for rapid disposition of our products
- Develop comprehensive operating plans and monitors the achievement of business and financial goals.
- Ability to manage multiple projects in a fast-paced environment
- Collaborate and lead effectively in a dynamic, cross-functional matrix environment
- Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement across the Value Stream
Here’s What You’ll Bring to the Table:
- A BS in engineering or sciences with 5-8 years’ experience in cGMP manufacturing processes in a pharmaceutical or biotechnology environment
- Thorough knowledge and understanding of cGMPs and FDA guidelines is required.
- Previous management and/or project management experience
- Subject Matter Expert on the set up/use/process of TFF Systems, Chromatography systems, single-use process materials/consumables is preferred.
- Technical writing skills and proficient in investigations and root cause analysis.