mRNA Manager, QC

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Job Description

Thermo Fisher Scientific Inc. is seeking a dynamic and transformative leader to fill the role of mRNA Manager, QC. This position is ideal for an individual with the ability to maintain and improve the quality of mRNA products to international standards. Join us in our mission to build a healthier, safer world, leading a dedicated QC team and implementing advanced analytical techniques.

Key Responsibilities:

Leadership:

• Lead the QC team towards improvement-focused goals.
• Set clear expectations and provide valuable, timely feedback.
• Develop innovative problem-solving techniques and foster a waste-free environment.

Quality Control:

• Lead all aspects of our QC laboratory, coordinate planning, task prioritization, comprehensive analyses, and insightful report delivery.
• Ensure our QC Chemistry, QC Biotechnology, and QC Microbiology teams provide timely, scientifically validated results in line with international regulatory guidelines and customer needs.

Technical Expertise:

• Supervise complex biological and physical characterization techniques, including LC-MS, UPLC/HPLC, molecular biology tests, Endotoxin, and Sterility tests.
• Implement QC processes in alignment with international mRNA quality standards set by globally recognized regulatory bodies.

Regulatory Compliance:

• Ensure the execution of qualification/validation protocols, batch release, and stability testing in accordance with regulatory standards.
• Improve and maintain quality systems for ongoing compliance and audit-readiness.

Collaboration & Innovation:

• Facilitate collaboration across departments to improve operational efficiency.
• Foster innovation in the PD lab, embracing brand new QC methodologies.

Planning for long-term success:

• Lead the development and implementation of QC plans to drive the success of our mRNA business.
• Find opportunities to improve processes and introduce standard methodologies to improve QC operations.

Qualifications:

• Advanced degree (Ph.D., MSc, or equivalent) in Chemistry, Biochemistry, Molecular Biology, or a related field.
• 10 to 15 years of experience in QC or manufacturing in the biopharmaceutical industry.
• Proven leadership skills with the ability to build and lead high-performing teams.
• Extensive knowledge of international regulatory guidelines (FDA, EMA, etc.), QC methodologies, and manufacturing practices.
• Strong analytical and problem-solving skills, with the ability to manage complex projects to completion.
• Excellent communication skills, with the ability to facilitate effective cross-functional collaborations.

Embrace this chance to create a significant impact in the scientific community. Apply today and let's explore the future together.

Join us!!