Supervisor – Manufacturing – Clinical Drug Product
| Company | Moderna |
|---|---|
| Location | Norwood, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Associate’s |
| Experience Level | Mid Level, Senior |
Requirements
- HS Diploma
- 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 experience
- Position requires working/standing in Grade C room for a minimum of 10 hours per day.
Responsibilities
- Safely and compliantly fill and label mRNA medicines
- Ensure 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 Facility
- Closely 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.
Preferred Qualifications
- Previous management of people and/or projects is preferred, along with a proven track record of developing, leading and sustaining a high performing team
- Subject Matter Expert on the set up/use/process of aseptic filling lines and labelling activities
- Thorough knowledge and understanding of cGMPs and FDA guidelines is required.