Operations Manager

DSJ - Exton, PA

Full-timeEstimated: $69,000 - $94,000 a year
EducationSkills

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

Experience:

  • Supervisor/Manager: 3 years (Preferred)
  • Validation: 4 years (Preferred)
  • Biotech: 5 years (Preferred)
  • Manufacturing: 5 years (Preferred)

Education:

  • Bachelor's (Required)