Description
Manufacturing Team Lead Summary
The Manufacturing Team Lead is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in the manufacturing of pharmaceutical drug products.
The primary responsibility of the Manufacturing Team Lead is to drive and support manufacturing activities in the area of equipment preparation, filling and formulation while providing in-process daily review of executed batch record and form entries. In addition, they will execute and perform standard work as per standard procedures and manufacturing batch records. They will be responsible for meeting/exceeding production standards, maintaining product quality, and minimizing/preventing equipment downtime. The ideal candidate will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors.
Essential Job Functions:
• Proven subject matter expert within manufacturing area with advanced troubleshooting, coordination, and communication skills
• Provide leadership to manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance
• May lead shift handover or act as a shift lead in the absence of a supervisor
• Leadership (Supervisory/Management) experience preferred
• Computer efficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software
• Assist Production Supervisor, supporting a team of 6 to 10 associates daily, to prepare and fill syringes and vials
• Follow production and manufacturing procedures
• Assist in writing and implementing area's process documents
• Operate equipment in compliance with SOPs
• Assure compliance with cGMP requirements (current good manufacturing practices)
• Complete and review associated production records, logbooks and forms
• Train new associates in accordance with inspector certification procedures
• Mentor new associates
• Train new employees to perform manufacturing inventory transactions in the ERP system
• Perform duties gowned in Grade C, D, and controlled non-classified cleanrooms
• Perform cleaning and sanitization activities as needed
• Collaborate and communicate with cross functional teams
• Work flexible hours to ensure production facility coverage
Minimum Education and Experience:
• High School diploma required
• Minimum 5 years of GMP pharmaceutical experience in drug product manufacturing
• Previous leadership experience is strongly preferred
• Initiative-taking and collaborative
• Ability to work with minimal supervision
Additional Preferences:
• Good math and documentation skills
• Ability to learn and adapt to innovative ideas
• Good observation skills
