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Supervisor - Upstream Manufacturing

System One Baltimore, MD Full-Time
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Job Title: Supervisor – Upstream Manufacturing
Location: Baltimore, MD
Employment: Direct Hire Full/time
Start Date: Immediate

Responsibilities:.  
  • The Manufacturing Supervisor will provide day to day oversight of the cleaning contractors; including scheduling activities, overseeing training and providing input regarding personnel changes.  
  • The Manufacturing Supervisor will actively perform activities and monitor activities in the cGMP manufacturing areas.
  • Performs and monitors day to day manufacturing operation activities and verifies compliant execution with cGMP standards and procedures from the cGMP manufacturing areas.
  • Demonstrates, understands and adheres to policies, GMP standards and safety procedures
  • Identify and appropriately escalate issues that require decisional activity in order to keep routing operations, projects and initiatives on schedule.
  • Responds to off-hour alarms as assigned by the Manufacturing Management team.
  •  Secure collaboration and support of manufacturing initiatives from required support departments.
  • Generates Batch Records, SOP’s and other controlled documentation as assigned by the Manufacturing Management Team.
  • Provide resources and subject matter expert (SME) input to support continuous improvement, capital and corporate initiatives.
  • Ensure personnel fully support compliance-based activities by maintaining current training requirements.
  • Coordinates daily tasks with managers and ensures completion.
  • Supports other process teams as necessary to achieve site and corporate goals.
  • Ensure the ongoing validated state of cGMP manufacturing processes as it relates to process performance.
  • Partner with Quality Assurance to ensure the highest level of compliance with cGMP with respect to the storage, use and documentation activities associated with the manufacture of bulk and finished product.
  • Actively supports the internal audit program as a means of driving continuous improvement throughout Manufacturing.
  • Ensure department compliance with all cGMP regulations as well as other areas of mandatory regulatory oversight.
  • Participate in and provide SME resources to support all regulatory audits and technical discussions.
  • Real time, on the floor, Batch Production Record review.
  • Actively participate in the installation, operation, cleaning and maintenance of bio-pharmaceutical cGMP equipment.
Requirements:
  • Bachelor’s Degree in a scientific/engineering discipline or equivalent related experience in cGMP biologics/pharmaceutical manufacturing.
  • Minimum of 4 years of cGMP bio-pharmaceutical experience with a minimum of 1 year of supervision/demonstrated leadership
  •  Knowledge of cGMP and CFR requirements.
  • Knowledge of SAP or equivalent ERP system
 

Recommended skills

Storage (Warehousing)
Scheduling
Pharmaceutical Manufacturing
Good Manufacturing Practices
Certified Global Meeting Planner
Operations
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Job ID: BHJOB18630_152922

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