JOB SUMMARY
Ensure the ongoing safe and compliant state of cGMP manufacturing processes as it relates to process execution and process performance.
Develop, coach, and mentor staff members through routine 1-on-1 interactions, IPMP goals, and defined major responsibilities.
The role of the Manufacturing Supervisor is to actively monitor and oversee activities in the cGMP manufacturing areas.
ESSENTIAL FUNCTIONS
Business:
- From the cGMP manufacturing areas, directly oversees day to day manufacturing operation activities and verifies safe and compliant execution with cGMP standards and procedures.
- Supports the development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, resource models.
- Assure communication of key Company/Department initiatives and objectives to staff .
- Facilitate Shift meetings and ensures that the appropriate level of communication is disseminated to the subsequent shift and other support departments regarding process and equipment status.
- Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions.
- Identify and appropriately escalate issues in order to keep routine operations, projects and initiatives on schedule.
- Effectively collaborates and integrates information from support departments to position teams f or success.
- 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.
Technical:
- Ensure the ongoing validated state of commercial cGMP manufacturing processes as it relates to process performance and process validation.
- 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 support and interact with the internal audit program as a means of driving continuous improvement throughout Manufacturing.
- Participate in and provide SME resources to support all regulatory audits and technical discussions.
- Track and communicate key performance indicators from tier 1 to tier 2 Integrated Process Teams.
- Real time, on the floor, Batch Production Record review.
- Participate with process performance monitoring.
Culture Management and Employee Development:
- Support corporate culture initiatives. Work effectively with peer management to build team relationships and position f or mutual success in alignment with Q12 principles .
- Actively support Lansing Great Place to Work programs through regular attendance, active participation in meetings, and implementation of concepts and principles in department management.
- Qualified Trainer development and routine assessment.
- Responsible f or directing the work of the team and managing their performance. Drives engagement of the team members by creating a positive work environment. Encourages the development and career growth of team members.
- 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 nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
EDUCATION, EXPERIENCE & SKILLS
- Bachelor's Degree is a scientific/engineering discipline preferred or equivalent related experience in cGMP biologics/pharmaceutical manufacturing.
- A minimum of three (3) years of progressive leadership responsibility required in an industry-related environment.
- Knowledge of global regulatory requirements.
- Strong communication skills: oral/written and listening.
- Behavioral Competencies: Ensures Accountability, Drives Engagement, Communicates Effectively, Collaborates, Builds Effective Teams
