Manufacturing Supervisor / Manager

Moderna

(Cambridge, Massachusetts)
Full Time
Job Posting Details
About Moderna
Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly.
Summary
The second shift manufacturing manager is a hands on front line management position.The Manufacturing Manager is accountable for production operations associated with the manufacture of clinical drugs following cGMP. The individual in this role will lead a cohesive team responsible for producing high quality mRNA-based medicines 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 regulatory requirements and Moderna’s Quality System.
Responsibilities
* Develop weekly/monthly goals and manages shift activities. * Oversee progress of daily schedule to ensure safe and timely completion of manufacturing activities * Point person for technical and compliance issues and liaison with internal groups (QA, QC, Regulatory etc.) to facilitate issue resolution. * Ensure functional unit's compliance with GMP and all its related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports and records. * Oversee the hiring, development, retention and performance of front line manufacturing staff.
Ideal Candidate
**Minimum Qualifications** * Requires BS in a relevant science or engineering discipline and a minimum of 5+ years’ experience in a biotechnology manufacturing/quality/development environment. * Thorough knowledge and understanding of cGMPs and FDA guidelines is required. **Preferred Qualifications** * Prior supervision of staff * 7+ years of professional/industrial cGMP experience in a biotech, diagnostic, therapeutic or pharma company * Subject Matter Expert on the set up/use/process of chromatography systems, TFF Systems, and single use process materials/consumables **Competencies** * Technical / Professional Knowledge * Technical Transfer * Aligning Performance for Success * Decision Making * Detail Oriented * Energy * Facilitating Change * Planning and Organizing * Safety Awareness * Stress Tolerance * Staff development

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