Supervisor, Manufacturing

Essential Duties and Responsibilities

• Solve or troubleshoot complex problems
• Accountability for floor operations and execution – directly impacting product, patient, and process.
• The leadership, management, and company vision necessary to ensuring the proper controls, Key Performance Indicators, people, and systems are in place within the manufacturing function.
• Work with department leadership and team to establish programs, practices, and processes that drive a high-performance culture and engaged workforce across Safety, Quality, Delivery, Cost and People.
• Escort Vendors / Visitors within MFG Cleanrooms
• Lead all day-to-day manufacturing operating activities including but not limited to:
• Manufacturing
• Manufacturing support
• Manufacturing compliance to ensure delivery of departmental commitments, achieving company objectives.
• Batch Record / Logbook reviews and approvals
• Review completion of MBRs; hand off to QA with accuracy / bringing MBRs to complete disposition.
• Create batch readiness task trackers and schedule MFG operations.
• Assist in planning, scheduling, and production functions to ensure adequate materials, equipment, and personnel are available to meet the production schedule.
• Support and Conduct Enrollment of Materials / Bill of Materials
• Create purchase requests / procure items as needed.
• Accountable for encouraging and enforcing a culture of compliance and continuous improvement surrounding Safety, Quality, Delivery, Cost and People.
• Aid in the development and implementation of Key Performance Indicators to track and lead successful, timely and achievable goals, objectives, and projects.
• Maintain department operational and capital budgets, responsible for driving financial results, and optimization of fixed and variable costs.
• Collaborate with team to develop a robust training program/strategy ensuring technician ownership and accountability.
• Work with team to develop and maintain operational excellence programs, such as 6S, lean manufacturing, and leadership standard work.
• Collective collaboration & goal setting with all other entities on site including Process Development, Quality Assurance, Quality Control, etc.
• Make decisions, based on professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.
• Evaluate the functional strengths and developmental continuous improvement opportunities within the GM manufacturing team and surrounding focus areas.
• Must stay current with relevant technologies and be forward-thinking to identify new approaches and opportunities.

Qualifications

• B.S. in Biology, Biochemistry, Chemistry, Engineering, or related field
• 1-4 years of hands-on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
• Preferred: 1-2 years in a Manufacturing/Operations Leadership role and leadership experience in a cGMP environment
• Ability to work by positively influencing peers and their reports and gain their cooperation.
• Ability to see the “big picture” while being capable of driving detailed and robust results in line with organizational strategy. A high sense of urgency and a commitment to delivering results is highly desirable.
• Experience in cell gene therapy manufacturing and/or aseptic processing.