Supervisor, mRNA Manufacturing

Overview

Supervisor, mRNA Manufacturing at Thermo Fisher Scientific (Monza site). The Supervisor will organize, coordinate and oversee manufacturing operations to ensure timely and high-quality product supply in a highly regulated environment, manage conflict to resolve issues, use practical process improvement (PPI) tools to reduce waste and improve operational efficiencies, product quality, and regulatory compliance, and utilize project management tools to implement plans to increase efficiency and decrease waste.

Responsibilities

• Supervise Daily Operations: Oversee daily operations of the mRNA Manufacturing department, including scheduling, workflow management, and resource allocation to ensure completion on time and compliance with safety, GMP, and other regulatory requirements.
• Manage inventory levels to prevent shortages and overstock situations.
• Ensure completion of routine and preventive maintenance and calibration, and qualification/validation of manufacturing equipment.
• Safety: Create and maintain a safe work environment by engaging associates in reporting potential safety hazards, supporting EH&S guidelines, and continually emphasizing safe work habits and conditions. Investigate safety problems, develop corrective actions with EH&S, and implement and communicate changes.
• Compliance and Quality Assurance: Ensure adherence to GMP and other regulatory requirements. Monitor production processes to ensure product quality and consistency. Investigate production problems and coordinate with appropriate functional areas to implement corrective actions.
• Documentation: Author and revise SOPs, BPRs, and JAs. Perform daily review and final sign-off of executed cGMP documentation (BPRs, forms).
• Training and Mentorship: Train, monitor, and mentor direct reports on manufacturing activities; mentor staff regarding safety and regulatory requirements.
• Audits and Regulatory Readiness: Conduct regular audits and inspections to verify compliance; prepare for and participate in regulatory inspections and audits.
• Team and Performance Management: Lead the Manufacturing Team (Lead, Team Leaders, Training and Documentation Officers, Operators and Technicians) with regular 1x1s. Develop direct reports, provide feedback, coaching, and development opportunities; maintain accountability and data-driven decision-making. Manage staffing and hiring processes as needed.
• Process, Safety and Quality Improvement: Ensure batch manufacturing readiness and meet production schedule deliverables; address obstacles with cross-functional teams to meet objectives and customer deliveries; promote cross-department collaboration to improve production quantity or quality; drive continuous process improvement initiatives.
• Other: Support safety, quality metrics and continuous improvement programs as part of daily operations.

Education

• Preferred: B.S. Degree in Biotechnology, Biology, Chemistry, Industrial or Chemical Engineering, or related field.

Experience

• 6 - 8 years of relevant pharma industry experience with experience managing and developing staff in manufacturing.
• Experience in Drug Substances and API productions, upstream (media preparation and enzymatic reactions in bioreactors) and downstream steps (TFF, chromatography, encapsulation, clarifications/filtrations), and process engineering.
• Practical application experience of PPI and Lean Manufacturing or other process improvement methodologies.

Knowledge, Skills, Abilities

• Advanced verbal and written communication skills with the ability to influence; strong problem-solving and analytical capabilities.
• Proven ability to achieve results, communicate effectively, and make sound decisions in uncertain conditions.
• Ability to follow complex procedures precisely.
• Ability to mentor, train, motivate and coach.
• Ability to challenge the status quo, show self-motivation, time management, and delegation.
• Strong conflict resolution skills; detail-oriented.

Join a dynamic team where you will lead the manufacturing team, drive continuous improvement, and ensure safety and quality standards are met. Bring your engineering/scientific background and your people management skills to make a significant impact.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Production, Supply Chain, and Manufacturing
• Industries: Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Thermo Fisher Scientific by 2x. Get notified about new Manufacturing Supervisor jobs in Monza, Lombardy, Italy.