Responsibilities for the Manager of Operations:
- Provide general supervision for cGMP suite cleaning and waste removal, stocking of consumables, and movement of raw materials and solutions within the cGMP suites.
- Provide training, and hands-on support of production staff in the operation of equipment to support preclinical, clinical phase, and commercial launch batches of all materials.
- Coordinate the preparation/revision of master batch records, SOPs, and review/close-out all cGMP documents, including equipment and process deviations for each campaign.
- Assist in troubleshooting equipment issues and batch/material related deviations. Provide timely reporting, investigation, and resolution of manufacturing process/product deviations, change controls, and commitments.
- Interact cross-functionally with Upstream and Downstream Operations, Facilities, Quality Assurance, Quality Control, VTE, and other internal and external functions to support successful batch production.
Job Qualifications for the Manager of Operations:
- Bachelors in biological sciences, engineering, or related field.
- 5-8 years in a Biopharmaceutical industry focusing on multi-discipline cGMP production environment, initiating, and scheduling.
- Minimum 3 years of Supervisor/Managerial experience
- Experience working with single-use equipment
- Knowledgeable in cGMP equipment validation, troubleshooting, and maintenance as well as the ability to identify, investigate, and solve process, product and equipment problems.
Job Type: Full-time
- Supervisor/Manager: 3 years (Preferred)
- Validation: 4 years (Preferred)
- Biotech: 5 years (Preferred)
- Manufacturing: 5 years (Preferred)