Mrna Qc Manager
1 mese fa
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
We are seeking the manager of mRNA QC at Thermo Fisher Scientific Inc. In this role, accountable for maintaining the quality of our mRNA products to meet global regulatory standards. You will be leading the QC team, coordinating advanced analytical techniques, and collaborating with customers to drive innovation and improvement. Your leadership will ensure compliance with FDA, EMA, and other regulatory agencies, contributing to a healthier and safer world.
**Key Responsibilities**:
Leadership and Development:
- Lead, mentor, and develop the QC team, encouraging a culture of high performance and continuous improvement.
- Set clear, comprehensive expectations and provide meaningful, timely feedback to staff.
- Empower team members to be innovative, eliminate waste, and address problems efficiently.
**Quality Control Management**:
- Coordinate all activities in the QC laboratory, including planning, prioritization of tasks, conducting analyses, and reporting findings.
- Ensure timely and scientifically sound output for the QC Chemistry, QC Biotechnology, and QC Microbiology teams, aligned with international regulatory guidelines and customer-specific requirements.
**Technical Oversight**:
- Manage the supervision of complex biological and physical characterization methods, such as LC-MS (sequencing), UPLC/HPLC (quantifying excipients, mapping, IEX, SEC), molecular biology tests (q-PCR, nucleic acid sequencing, structure), SDS-APGE, EEndotoxin, and Sterility tests.
- Ensure the QC of Raw Material and processes for mRNA products align with international quality requirements established by regulatory agencies like the FDA and EMA.
**Regulatory Compliance**:
- Ensure the completion of qualification/validation protocols, batch release, Certificat of Analysis (CoA), and stability testing in compliance with regulatory standards.
- Maintain and improve quality systems to ensure ongoing compliance and readiness for regulatory audits.
**Collaboration and Innovation**:
- Partner proactively with key collaborators across departments to improve product quality and operational efficiency.
- Support the Process Development (PD) lab and foster innovation in new QC methodologies, staying up-to-date with industry trends through experience.
**Planning for Success**:
- Contribute to planning and implementing QC initiatives to support the growth and success of the mRNA business, including new technologies, equipment, and facilities.
- Find opportunities to improve processes and implement standard methodologies to improve QC operations.
**Qualifications**:
- Advanced degree or equivalent experience (Ph.D., MSc, or equivalent) in Chemistry, Biochemistry, Molecular Biology, or a related field.
- Extensive experience (10 to 15 years) in quality control or manufacturing within the biopharmaceutical industry.
- Proven leadership experience with a track record of developing and managing high-performing teams.
- In-depth knowledge of international regulatory guidelines (FDA, EMA, etc.) and QC methodologies or manufacturing environment.
- Strong analytical and problem-solving skills, with the ability to manage complex projects and deliver results.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
Join us
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