Manufacturing Supervisor

Role Summary

Manufacturing Supervisor

Responsibilities

• Accountable and responsible for leading assigned production staff to achieve targets and deliver and improve process or product consistency, quality/compliance, cost standards and customer service.
• Responsible for planning, organizing, staffing, performance assessment, salary recommendations, and employee counseling for a group of employees typically with similar technical responsibilities.
• Ensures that work performed by the assigned staff is accurate, timely, efficient, and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations.
• Participates in investigations and continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and/or cycle time.
• Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are accurate and complete.
• Has a basic understanding of product cost structure, budgeting process, and spending.
• Optimizes resources to maximize production and ensure quality and safety standards.
• Focuses on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
• Knows the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise, and coach their teams.
• Holds recurring conversations with team to solicit feedback and identify ways to promote a culture of procedural compliance and strong data management practices.
• Ensures a safe work environment. Ability to identify, evaluate, and correct potential hazards in the workplace is essential.
• Coordinates, schedules, and participates in daily activities of cGMP production in the manufacturing area to meet supply chain needs.
• Must be flexible to work rotating shifts to support 24/7 operation.
• Ensures that product quality is maintained through all phases of commercial and clinical production including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics, and integrated utilities to identify and resolve quality risk to commercial and clinical manufacturing. General knowledge of scientific principles, production equipment and related procedures.
• Aids in investigations. Responsible for the adherence to established policies, procedures, and practices. Participates in site inspections and cGMP and Quality decisions effecting short term production
• Provides supervision to direct reports. Motivates personnel by setting high standards, encourage teamwork; clear, unambiguous communication is critical.
• Primary contact for all personnel issues occurring with their direct reports. Responsible for development plans and personnel reviews. Makes initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, Emergency situations, including injured employees, facility issues, and inclement weather.
• Reviews completed batch records. Supports the development of training material, update curricula, close training gaps, support the training of new supervisors/operators.
• Advises management of non-conformance issues and opportunities for continuous improvement
• Provides input on primary decisions on cGMP related documents developed or revised.
• Articulates challenges and solutions to technical and non-technical peers and to department management.
• Provides technical guidance and act as a departmental liaison with primary support groups.
• Responsible for short range planning (scheduling daily and weekly operations and staff) and longer range planning (facilities shutdowns and preventive maintenance).

Qualifications

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
• Strong people management skills.
• Ability to identify, evaluate, and correct potential hazards in the workplace.
• Experience in pharmaceutical manufacturing or a related field.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Proficiency in managing quality, compliance, and customer service.

Skills

• General knowledge of scientific principles.
• In depth knowledge of biopharmaceutical unit operations.
• Experience with production equipment and related procedures.
• Experience in process improvement and innovation.
• Ability to work collaboratively with cross-functional teams.
• Previous Leadership, Supervisory or management experience is preferred.

Education

• Not specified beyond the qualifications above.

Additional Requirements

• Physical/Mental Requirements: Working knowledge of vaccine or biotechnology product manufacturing in a cGMP environment; moderate repetitive standing, sitting, bending, ladder climbing, pushing and lifting up to 40 lbs; aseptic gowning required on manufacturing floor.
• Non-standard Work Schedule, Travel Or Environment Requirements: Two positions are 12 hour Day Shift (Rotation of 3, 2, 2 schedule); Two positions are 12 hour Night Shift (Rotation of 3, 2, 2 schedule).