Supervisor, Downstream Manufacturing
Workforce Genetics Baltimore, MD
- Posted: 24 days ago
Are you looking to join a company that has an outstanding history of developing and producing biodefense and lifesaving drugs and has signed deals with some of the largest drug development companies to manufacture the next COVID vaccine?
Are you looking for a job with a mission-oriented biotech where you can have a real impact at work and in the world?
A company where you feel a sense of ownership in your future, where you feel like you advancing in your career? If so, look no further.
Our client is looking for a Manufacturing Supervisor, Downstream who will report to the Manager, Manufacturing. Prior experience in cGMP manufacturing, operation of process equipment, and aseptic technique are prerequisites. 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.
II: Essential Functions
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 company 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, SOPs, 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.
Culture Management and Employee Development:
Support corporate culture initiatives. Work effectively with peer managers to build team relationships.
Actively support Management Development programs through regular attendance, active participation in meetings, and implementation of concepts and principles in department management.
Establish and maintain routine management tools and standards to assure that direct reports are utilizing common tools to track resources, time coding, and performance.
Ensure successful IPMP process execution to drive consistency between company/department goals and objectives and day-to-day business operations.
Effectively build and maintain working relationships between Manufacturing Operations and support departments.
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