II: Essential Responsibilities
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 the company’s 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.
Culture Management and Employee Development:
Support corporate culture initiatives. Work effectively with peer management 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.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
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.
Strong communication skills: oral/written and listening.
Knowledge of SAP or equivalent ERP system
Personal Competencies: Self-awareness, Integrity, Team player, Creative, Highly Motivated.