Supervisor, mRNA Manufacturing
Supervisor, mRNA Manufacturing
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
The mRNA Manufacturing Process Unit of ThermoFisher Monza site is looking for a Manufacturing Supervisor!
The Supervisor will organize coordinate and oversee manufacturing operations to ensure timely and high-quality products 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.
The ideal candidate will possess a strong technical background a robust quality mindset and exceptional personnel management and leadership skills.
What will you do
- 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 all safety Good Manufacturing Practices 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 the associates in reporting potential safety hazards supporting the EH&S guidelines and continually emphasizing safe work habits and working conditions. Investigate safety problems develop corrective actions with EH&S and implement and communicate changes.
- Compliance and Quality Assurance:
- Ensure adherence to GMP (Good Manufacturing Practices) and other regulatory requirements. Monitor production processes to ensure product quality and consistency.
- Investigate production problems and failures. Identify possible causes and coordinate with appropriate functional areas in finding solutions and implementing corrective actions.
- Author and revise Standard Operating Procedures (SOPs) Batch Production Records (BPRs) and Job Aids (JAs). Perform daily review and final sign-off of executed cGMP documentation (BPRs forms).
- Train monitor and mentor direct reports on manufacturing activities. Mentor staff regarding safety aspects and regulatory requirements.
- Conduct regular audits and inspections to verify compliance with GMP SOPs and other regulatory requirements.
- Prepare for and participate in regulatory inspections and audits.
- Team and Performance Management:
- Lead the Manufacturing Team which includes Lead Team Leaders and Training and Documentation Officers (direct reports) and Operators and Technicians (indirect reports) and conduct regular 1x1s.
- Develop direct reports by providing exciting tasks and assignments and optimally using the PMD (Performance Management Development process) and regular one-on-one meetings. Set clear objectives and provide developmental feedback conduct employee coaching and counseling for attendance performance and adherence to company policies and procedures.
- Cultivate an environment of accountability and data-driven decision-making.
- Maintain appropriate staffing interview applicants and hire qualified candidates.
- Process Safety and Quality Improvement:
- Ensure batch manufacturing readiness and meet the production schedule deliverables.
- Take charge of the daily production schedule addressing any obstacles and collaborating closely with cross-functional departments to meet business objectives and customer deliveries.
- Promote production effectiveness by communicating and cooperating with other departments and shifts to maintain or improve the quantity or quality of production.
- Drive and support continuous process improvement initiatives to achieve strong safety performance product quality finance and process efficiency.
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 and managing and developing staff in manufacturing.
- Experience in Drug Substances and API Productions and in main Upstream (Media Preparation and Enzymatic reactions in Bioreactors) and in 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 and an ability to influence advanced problem-solving skills and analytical capability.
- Proven ability to achieve results communicate effectively and make sound decisions in uncertain conditions.
- Ability to accurately follow complex procedures.
- Ability to mentor train motivate and coach.
- Ability to challenge the status quo show self-motivation proven time management and ability to delegate.
- Strong conflict resolution skills.
- Detail oriented.
Join a dynamic team where youll lead 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!
Required Experience:
Manager
Employment Type
Full-Time
