Mrna Qc Manager

2 settimane fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**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

  • Mrna Qc Manager

    2 settimane fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    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...

  • Intern, Mrna Qc Laboratory

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **QC mRNA laboratory Intern for the new mRNA Business Unit (Monza)** Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex...

  • Team Leader, Chem Qc Mrna

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the...

  • Micro Qc Mrna Analyst

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the...

  • Biotech Qc Mrna Analyst

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Qc Biochemical Technician

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Biotech Qc Mrna Analyst

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Qc Mrna Material Readiness

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. ha come missione di rendere il mondo più sano, più pulito e più sicuro. Sia che i nostri clienti stiano portando avanti la ricerca nel campo delle scienze della vita, risolvendo complesse sfide analitiche, aumentando l'efficienza nei loro laboratori, migliorando la salute dei pazienti attraverso la diagnostica o lo sviluppo e...

  • Chem Qc Mrna Analyst

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the...

  • Supervisor Quality Control Mrna

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...

  • Mrna Formulation Scientist

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...

  • Mrna Formulation Scientist

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...

  • Chem Qc Mrna Analyst

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the...

  • mRNA Process Development Scientist

    2 settimane fa

    Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

    About the RoleWe are seeking a highly skilled mRNA Process Development Scientist to join our team at Thermo Fisher Scientific.Key ResponsibilitiesDevelop and optimize downstream processes for mRNA purification using liquid chromatography and TFF.Conduct feasibility assessments, technical consultations, training, and bench trials to support process...

  • Progetto del Dipartimento mRNA

    3 settimane fa

    Monza, Lombardia, Italia Adecco Italia S.P.A. A tempo pieno

    Adecco Italia S.P.A. cerca un/a Specialista in Produzione mRNA per il suo team di esperti del settore chimico farmaceutico. Il candidato ideale sarà coinvolto nella gestione delle attività di qualifica relative alle mRNA facilities e nella stesura e revisione dei processi e procedure. Altri compiti includono la pianificazione e la gestione dei progetti di...

  • Mrna/lnp Process Development Scientist

    3 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of more than $40 billion. Whether our customers are accelerating life...

  • Mrna Scientist

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing productivity in their laboratories, improving...

  • Qc Documentation Officer

    5 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific, World leader in Serving Science sta reperendo per la sua nuova Business Unit dedicata alla tecnologia mRNA un QC Biochem Analyst specialist. La risorsa, all''interno del gruppo QC Biochemical laboratory, si occuperà principalmente di: - Revisione delle procedure operative standard e relativa documentazione associata in...

  • Qc Documentation Officer

    6 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific, World leader in Serving Science sta reperendo per la sua nuova Business Unit dedicata alla tecnologia mRNA un QC Biochem Analyst specialist. La risorsa, all'interno del gruppo QC Biochemical laboratory, si occuperà principalmente di: - Revisione delle procedure operative standard e relativa documentazione associata in...

  • Mrna Process Development Scientist

    3 mesi fa

    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether...